Trial Outcomes & Findings for Prebiotic GOS and Lactoferrin With Iron Supplements (NCT NCT03866837)
NCT ID: NCT03866837
Last Updated: 2025-01-08
Results Overview
The primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 1 month.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
288 participants
Primary outcome timeframe
1 month
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
Study Group A: MMP + Iron + GOS
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Baseline
STARTED
|
72
|
72
|
72
|
72
|
|
Baseline
COMPLETED
|
72
|
72
|
72
|
72
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1 Month Intervention
STARTED
|
70
|
72
|
70
|
70
|
|
1 Month Intervention
COMPLETED
|
70
|
72
|
70
|
70
|
|
1 Month Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
6 Months Intervention
STARTED
|
65
|
66
|
65
|
68
|
|
6 Months Intervention
COMPLETED
|
65
|
66
|
65
|
68
|
|
6 Months Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
9 Months Intervention
STARTED
|
64
|
66
|
65
|
65
|
|
9 Months Intervention
COMPLETED
|
64
|
66
|
65
|
65
|
|
9 Months Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.07 months
STANDARD_DEVIATION 0.42 • n=72 Participants
|
6.17 months
STANDARD_DEVIATION 0.32 • n=72 Participants
|
6.15 months
STANDARD_DEVIATION 0.37 • n=72 Participants
|
6.27 months
STANDARD_DEVIATION 0.35 • n=72 Participants
|
6.11 months
STANDARD_DEVIATION 0.40 • n=288 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
144 Participants
n=288 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
36 Participants
n=72 Participants
|
144 Participants
n=288 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Kenya
|
72 participants
n=72 Participants
|
72 participants
n=72 Participants
|
72 participants
n=72 Participants
|
72 participants
n=72 Participants
|
288 participants
n=288 Participants
|
|
log(10) Beneficial to Harmful Bacteria Ratio
|
2.279 log(10) ratio
STANDARD_DEVIATION 19.338 • n=72 Participants
|
2.553 log(10) ratio
STANDARD_DEVIATION 21.663 • n=72 Participants
|
2.070 log(10) ratio
STANDARD_DEVIATION 17.565 • n=72 Participants
|
1.956 log(10) ratio
STANDARD_DEVIATION 16.597 • n=72 Participants
|
2.215 log(10) ratio
STANDARD_DEVIATION 37.582 • n=288 Participants
|
PRIMARY outcome
Timeframe: 1 monthThe primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 1 month.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=70 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=70 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=70 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 1 Month
|
2.208 (unitless)
Standard Error 0.202
|
1.530 (unitless)
Standard Error 0.207
|
2.075 (unitless)
Standard Error 0.220
|
1.292 (unitless)
Standard Error 0.176
|
SECONDARY outcome
Timeframe: 6 monthsA key secondary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 6 months.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=65 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=66 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=65 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=68 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 6 Months
|
1.575 (unitless)
Standard Error 0.169
|
1.699 (unitless)
Standard Error 0.205
|
1.779 (unitless)
Standard Error 0.215
|
1.646 (unitless)
Standard Error 0.200
|
SECONDARY outcome
Timeframe: 9 monthsA key secondary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) to beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera in fecal microbiota as determined by quantitative polymerase chain reaction (qPCR) at 9 months.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=64 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=66 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=65 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=65 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 9 Months
|
2.084 (unitless)
Standard Error 0.192
|
1.881 (unitless)
Standard Error 0.183
|
1.916 (unitless)
Standard Error 0.257
|
1.748 (unitless)
Standard Error 0.201
|
SECONDARY outcome
Timeframe: 1, 6 and 9 monthsPopulation: 8 participants in Group A, 6 participants in Group B, 7 participants in Group C, and 7 participants in Group D withdrew during the duration of the study.
A secondary outcome measure will be the microbiota composition among study groups as determined by quantitative polymerase chain reaction (qPCR) measures of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic E. coli, C. difficile, members of the C. perfringens group, B. cereus, S. aureus, sum of Shigella spp., and Salmonella) and of beneficial (bifidobacteria and the group of Lactobacillus/Leuconostoc/Pediococcus spp.) bacterial genera at 1, 6, and 9 months. This outcome is reported as the mean log10 fold change from the beneficial to harmful bacteria ratio (BHR) of the baseline microbiota composition, abbreviated as "log10 FC in BHR".
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Microbiota Composition as Determined by Quantitative Polymerase Chain Reaction (qPCR).
1 month
|
-0.022 log 10 (fold change)
Standard Error 0.258
|
-1.025 log 10 (fold change)
Standard Error 0.239
|
-0.002 log 10 (fold change)
Standard Error 0.314
|
-0.637 log 10 (fold change)
Standard Error 0.239
|
|
Microbiota Composition as Determined by Quantitative Polymerase Chain Reaction (qPCR).
6 months
|
-0.742 log 10 (fold change)
Standard Error 0.247
|
-0.786 log 10 (fold change)
Standard Error 0.291
|
-0.308 log 10 (fold change)
Standard Error 0.306
|
-0.241 log 10 (fold change)
Standard Error 0.284
|
|
Microbiota Composition as Determined by Quantitative Polymerase Chain Reaction (qPCR).
9 months
|
-0.269 log 10 (fold change)
Standard Error 0.290
|
-0.607 log 10 (fold change)
Standard Error 0.314
|
-0.174 log 10 (fold change)
Standard Error 0.351
|
-0.114 log 10 (fold change)
Standard Error 0.284
|
SECONDARY outcome
Timeframe: Up to 9 monthsA secondary outcome measure will be the prevalence of diarrhea among study groups.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Diarrhea
|
7 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsA secondary outcome measure will be the prevalence of malaria among study groups.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Malaria
|
7 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 9 monthsPopulation: 8 participants in Group A, 6 participants in Group B, 7 participants in Group C, and 7 participants in Group D withdrew during the duration of the study.
A secondary outcome measure will be the proportion of participants with anemia among study groups, defined as Hemoglobin \< 11.5 g/L by laboratory diagnosis.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Proportion of Participants Who Experienced Anemia
1 month
|
0.43 Proportion of participants
|
0.49 Proportion of participants
|
0.57 Proportion of participants
|
0.56 Proportion of participants
|
|
Proportion of Participants Who Experienced Anemia
6 months
|
0.35 Proportion of participants
|
0.33 Proportion of participants
|
0.31 Proportion of participants
|
0.31 Proportion of participants
|
|
Proportion of Participants Who Experienced Anemia
9 months
|
0.36 Proportion of participants
|
0.45 Proportion of participants
|
0.31 Proportion of participants
|
0.23 Proportion of participants
|
|
Proportion of Participants Who Experienced Anemia
Baseline
|
0.43 Proportion of participants
|
0.54 Proportion of participants
|
0.61 Proportion of participants
|
0.49 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 9 monthsPopulation: 8 participants in Group A, 6 participants in Group B, 7 participants in Group C, and 7 participants in Group D withdrew during the duration of the study.
A secondary outcome measure will be the proportion of participants with iron deficiency among study groups, defined as plasma Ferritin \< 12 µg/L or/and soluble transferrin receptor (sTfR) \> 8.3 mg/L
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Proportion of Participants Who Experienced Iron Deficiency
Baseline
|
0.66 Proportion of participants
|
0.61 Proportion of participants
|
0.61 Proportion of participants
|
0.58 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency
1 month
|
0.3 Proportion of participants
|
0.3 Proportion of participants
|
0.39 Proportion of participants
|
0.37 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency
6 months
|
0.65 Proportion of participants
|
0.68 Proportion of participants
|
0.60 Proportion of participants
|
0.60 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency
9 months
|
0.65 Proportion of participants
|
0.73 Proportion of participants
|
0.66 Proportion of participants
|
0.63 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 9 monthsPopulation: 8 participants in Group A, 6 participants in Group B, 7 participants in Group C, and 7 participants in Group D withdrew during the duration of the study.
A secondary outcome measure will be the proportion of participants with iron deficiency anemia among study groups, defined as Hemoglobin \< 11.5 g/L and Soluble transferrin receptor (sTfR) \> 8.3 mg/L
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Proportion of Participants Who Experienced Iron Deficiency Anemia (IDA)
1 month
|
0.59 Proportion of participants
|
0.58 Proportion of participants
|
0.6 Proportion of participants
|
0.59 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency Anemia (IDA)
6 months
|
0.29 Proportion of participants
|
0.30 Proportion of participants
|
0.22 Proportion of participants
|
0.26 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency Anemia (IDA)
Baseline
|
0.34 Proportion of participants
|
0.39 Proportion of participants
|
0.45 Proportion of participants
|
0.39 Proportion of participants
|
|
Proportion of Participants Who Experienced Iron Deficiency Anemia (IDA)
9 months
|
0.29 Proportion of participants
|
0.39 Proportion of participants
|
0.22 Proportion of participants
|
0.22 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month, 6 months, 9 monthsPopulation: 8 participants in Group A, 6 participants in Group B, 7 participants in Group C, and 7 participants in Group D withdrew during the duration of the study.
A secondary outcome measure will be the proportion of participants with inflammation among study groups, defined as C-reactive protein (CRP) \> 5 mg/L
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Proportion of Participants Who Experienced Inflammation
Baseline
|
0.09 Proportion of participants
|
0.15 Proportion of participants
|
0.15 Proportion of participants
|
0.14 Proportion of participants
|
|
Proportion of Participants Who Experienced Inflammation
1 month
|
0.12 Proportion of participants
|
0.11 Proportion of participants
|
0.13 Proportion of participants
|
0.14 Proportion of participants
|
|
Proportion of Participants Who Experienced Inflammation
6 months
|
0.18 Proportion of participants
|
0.17 Proportion of participants
|
0.20 Proportion of participants
|
0.18 Proportion of participants
|
|
Proportion of Participants Who Experienced Inflammation
9 months
|
0.13 Proportion of participants
|
0.20 Proportion of participants
|
0.18 Proportion of participants
|
0.18 Proportion of participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsA secondary outcome measure will be the prevalence of Respiratory tract infections among study groups.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Respiratory Tract Infections
|
40 Participants
|
36 Participants
|
41 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsA secondary outcome measure will be the prevalence of other illnesses among study groups.
Outcome measures
| Measure |
Study Group A: MMP + Iron + GOS
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: MMP + Iron + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: MMP + Iron + GOS + bLF
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: MMP + Iron
n=72 Participants
This study group received daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Other Illnesses
Cold
|
16 Participants
|
10 Participants
|
17 Participants
|
28 Participants
|
|
Other Illnesses
Dermatitis
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Other Illnesses
Folliculitis
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Other Illnesses
Skin infection
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Other Illnesses
Gastritis
|
3 Participants
|
0 Participants
|
7 Participants
|
8 Participants
|
|
Other Illnesses
Gastroenteritis
|
1 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Other Illnesses
Impetigo
|
3 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Other Illnesses
Pneumonia
|
12 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Other Illnesses
Rhinitis
|
7 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Other Illnesses
Scabies
|
4 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Other Illnesses
Tinea capitis
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Study Group A: GOS
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Study Group B: bLF
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Study Group C: GOS + bLF
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Study Group D: Iron
Serious events: 1 serious events
Other events: 65 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Study Group A: GOS
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Galacto-oligosaccharides: Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: bLF
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Bovine lactoferrin: Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: GOS + bLF
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Galacto-oligosaccharides: Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.
Bovine lactoferrin: Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: Iron
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Infections and infestations
Severe malaria
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
General disorders
Hospitalization due to pneumonia
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
Other adverse events
| Measure |
Study Group A: GOS
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) and galacto-oligosaccharides (GOS), 7.5 mg.
Galacto-oligosaccharides: Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group B: bLF
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), bovine lactoferrin (bLF), 1.0 g.
Bovine lactoferrin: Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group C: GOS + bLF
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]), galacto-oligosaccharides (GOS), 7.5 mg, and bovine lactoferrin (bLF), 1.0 g.
Galacto-oligosaccharides: Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.
Bovine lactoferrin: Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
Study Group D: Iron
n=72 participants at risk
This study group will receive daily in-home fortification for 6 months with multiple micronutrient powders with 5 mg iron (as sodium iron EDTA \[2.5 mg\] and ferrous fumarate \[2.5 mg\]) alone, with no galacto-oligosaccharides (GOS), and no bovine lactoferrin (bLF).
Multiple micronutrient powders with 5 mg iron: The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg \[(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg\].
|
|---|---|---|---|---|
|
Infections and infestations
Cold
|
22.2%
16/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
13.9%
10/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
23.6%
17/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
38.9%
28/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
6/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Infections and infestations
Cutaneous larva migrans
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
7/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
8.3%
6/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
9.7%
7/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
General disorders
Fever
|
11.1%
8/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
0.00%
0/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
9.7%
7/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
11.1%
8/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Infections and infestations
Impetigo
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Infections and infestations
Malaria
|
9.7%
7/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
General disorders
Pneumonia
|
16.7%
12/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
8.3%
6/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
11.1%
8/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
General disorders
Rhinitis
|
9.7%
7/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Skin and subcutaneous tissue disorders
Scabies
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
8.3%
6/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
8.3%
6/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Infections and infestations
Skin infection
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
6.9%
5/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
2.8%
2/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Infections and infestations
Tinea capitis
|
5.6%
4/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
4.2%
3/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
1.4%
1/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection (URTI)
|
55.6%
40/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
50.0%
36/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
56.9%
41/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
52.8%
38/72 • 9 months
All adverse events reported here represent the clinical (observational) impression of the caregivers.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place