Trial Outcomes & Findings for Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India (NCT NCT02233764)
NCT ID: NCT02233764
Last Updated: 2026-03-09
Results Overview
Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
223 participants
Primary outcome timeframe
Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
FeZnPM
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
111
|
|
Overall Study
COMPLETED
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
22
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Children with available blood data were included in the analysis.
Baseline characteristics by cohort
| Measure |
FeZnPM
n=112 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=111 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
112 Participants
n=112 Participants
|
111 Participants
n=111 Participants
|
223 Participants
n=223 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Age, Continuous
|
14.4 months
n=112 Participants
|
14.9 months
n=111 Participants
|
14.6 months
n=223 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=112 Participants
|
57 Participants
n=111 Participants
|
116 Participants
n=223 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=112 Participants
|
54 Participants
n=111 Participants
|
107 Participants
n=223 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Asian
|
112 Participants
n=112 Participants
|
111 Participants
n=111 Participants
|
223 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=112 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=223 Participants
|
|
Iron status
|
10.6 g/dL
n=112 Participants
|
10.4 g/dL
n=111 Participants
|
10.5 g/dL
n=223 Participants
|
|
Physical Growth
|
-1.2 z-score
n=112 Participants
|
-1.4 z-score
n=111 Participants
|
-1.3 z-score
n=223 Participants
|
|
Iron Status BRINDA Adjusted
|
6.3 µg/L
n=104 Participants • Children with available blood data were included in the analysis.
|
5.9 µg/L
n=99 Participants • Children with available blood data were included in the analysis.
|
6.2 µg/L
n=203 Participants • Children with available blood data were included in the analysis.
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)As determined by hemoglobin concentration
Outcome measures
| Measure |
FeZnPM
n=69 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=63 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Hemoglobin (g/dL)
|
10.90 g/dL
Interval 10.0 to 11.4
|
10.30 g/dL
Interval 9.6 to 11.1
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)As determined by hemoglobin concentration
Outcome measures
| Measure |
FeZnPM
n=69 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=63 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Hemoglobin (g/dL)
|
0.10 g/dL
Interval -0.6 to 0.9
|
-0.20 g/dL
Interval -1.1 to 0.5
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Determined by serum ferritin
Outcome measures
| Measure |
FeZnPM
n=68 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=61 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Iron Status
|
-1.65 µg/L
Interval -7.7 to 2.2
|
-2.50 µg/L
Interval -7.2 to -0.2
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Determined by serum ferritin
Outcome measures
| Measure |
FeZnPM
n=70 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=63 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Iron Status
|
7.30 µg/L
Interval 3.6 to 12.1
|
4.70 µg/L
Interval 2.8 to 11.8
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Determined by serum ferritin BRINDA adjusted
Outcome measures
| Measure |
FeZnPM
n=70 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=63 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Iron Status BRINDA Adjusted
|
5.27 µg/L
Interval 2.99 to 8.74
|
3.62 µg/L
Interval 2.11 to 8.69
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Serum ferritin BRINDA adjusted
Outcome measures
| Measure |
FeZnPM
n=68 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=61 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Iron Status BRINDA Adjusted
|
-1.27 µg/L
Interval -6.34 to 1.37
|
-1.99 µg/L
Interval -5.78 to 0.04
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Outcome measures
| Measure |
FeZnPM
n=90 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=89 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Physical Growth
|
-1.6 z score
Interval -2.3 to -0.8
|
-1.5 z score
Interval -2.3 to -0.9
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Full scale name: Length-for-age Z-score (child's recumbent length as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates stunting.
Outcome measures
| Measure |
FeZnPM
n=90 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=89 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Physical Growth
|
-0.2 z score
Interval -0.6 to 0.2
|
-0.2 z score
Interval -0.6 to 0.2
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Outcome measures
| Measure |
FeZnPM
n=90 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=89 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Physical Growth
|
-1.5 z score
Interval -2.1 to -0.8
|
-1.6 z score
Interval -2.2 to -0.5
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Full scale name: Weight-for-age Z-score (child's body weight as compared to their age). Meaning of the Z-score central value: 0 represents the population median as indicated by the WHO Growth Standards. Standard deviations below the median represent a worse outcome. A Z-score ≤ -2 indicates underweight.
Outcome measures
| Measure |
FeZnPM
n=90 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=89 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Physical Growth
|
-0.2 z score
Interval -0.6 to 0.0
|
-0.2 z score
Interval -0.5 to 0.0
|
PRIMARY outcome
Timeframe: Last Visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Population: Children with reported vaccination of the measles-containing vaccine confirmed by maternal-child health card and available anti-measles immunoglobulin G titer.
Immune responses primarily defined as protective anti-measles IgG titers (\>16.5 AU/mL).
Outcome measures
| Measure |
FeZnPM
n=69 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=58 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Immune Function
|
56 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and last visit (last visit participant was observed for follow-up, between 2 and 9 months after baseline)Population: Children with reported vaccination of the measles-containing vaccine confirmed by maternal-child health card and available anti-measles immunoglobulin G titer at both baseline and endpoint to calculate change in measles IgG titer over time
Immune responses primarily defined as response to measles vaccine
Outcome measures
| Measure |
FeZnPM
n=36 Participants
The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
FeZnPM: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
CtrlPM
n=29 Participants
The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
CtrlPM: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
|
|---|---|---|
|
Immune Function
|
23.08 AU/mL
Interval -9.9 to 79.53
|
0.74 AU/mL
Interval -12.44 to 37.0
|
Adverse Events
FeZnPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CtrlPM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place