Trial Outcomes & Findings for Sub-clinical Inflammation and Iron Supplementation (NCT NCT01198574)
NCT ID: NCT01198574
Last Updated: 2012-05-22
Results Overview
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
402 participants
Primary outcome timeframe
at week 0, week 6 and week12
Results posted on
2012-05-22
Participant Flow
Screening for the study subjects was conducted in July, 2010 among the adolescent schoolgirls in Nyaung Done Township, Irrawaddy Division. It included assessment of Hb status using the Coulter Counter. Information on the general characteristics and menarche status of the girls are obtained.
Deworming with 400 mg Albendazole was done one week before the baseline data collection.
Participant milestones
| Measure |
Iron Group
Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
|
Vitamin A Group
Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
|
Iron and Vitamin A Group
Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
|
Placebo Group
Placebo group received 2.5 mg folic acid weekly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
102
|
100
|
102
|
|
Overall Study
COMPLETED
|
94
|
101
|
99
|
98
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Iron Group
Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
|
Vitamin A Group
Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
|
Iron and Vitamin A Group
Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
|
Placebo Group
Placebo group received 2.5 mg folic acid weekly
|
|---|---|---|---|---|
|
Overall Study
Resigned from schools
|
4
|
1
|
1
|
4
|
Baseline Characteristics
Sub-clinical Inflammation and Iron Supplementation
Baseline characteristics by cohort
| Measure |
Iron Group
n=98 Participants
Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
|
Vitamin A Group
n=102 Participants
Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
|
Iron and Vitamin A Group
n=100 Participants
Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
|
Placebo Group
n=102 Participants
Placebo group received iron placebo containing 2.5 mg folic acid weekly
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
98 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
402 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age Continuous
|
15.9 years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
16.1 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
16.1 years
STANDARD_DEVIATION 1.2 • n=206 Participants
|
15.8 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
16.0 years
STANDARD_DEVIATION 1.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
402 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Myanmar
|
98 participants
n=99 Participants
|
102 participants
n=107 Participants
|
100 participants
n=206 Participants
|
102 participants
n=7 Participants
|
402 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: at week 0, week 6 and week12Population: Per Protocol
Haemoglobin level (g/L) measured by cyanmethaemoglobin method
Outcome measures
| Measure |
Iron Group
n=94 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
|
Vitamin A Group
n=101 Participants
15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
|
Iron and Vitamin A Group
n=98 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
|
Placebo Group
n=98 Participants
2.5 mg folic acid + Vitamin A placebo
|
|---|---|---|---|---|
|
Haemoglobin Level
Hb week 0 (Baseline)
|
88.3 g/L
Standard Deviation 11.2
|
89.2 g/L
Standard Deviation 11.5
|
88.4 g/L
Standard Deviation 12.1
|
89.6 g/L
Standard Deviation 12.7
|
|
Haemoglobin Level
Hb week 12 (Endline)
|
110.8 g/L
Standard Deviation 9.8
|
109.0 g/L
Standard Deviation 9.1
|
111.4 g/L
Standard Deviation 9.0
|
109.7 g/L
Standard Deviation 8.4
|
|
Haemoglobin Level
Hb week 6 (Midline)
|
98.1 g/L
Standard Deviation 10.6
|
98.7 g/L
Standard Deviation 9.6
|
99.2 g/L
Standard Deviation 10.0
|
98.3 g/L
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: at week 0, week 6 and week12Population: Per Protocol analysis
Tissue iron store was measured by serum ferritin
Outcome measures
| Measure |
Iron Group
n=94 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
|
Vitamin A Group
n=101 Participants
15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
|
Iron and Vitamin A Group
n=98 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
|
Placebo Group
n=98 Participants
2.5 mg folic acid + Vitamin A placebo
|
|---|---|---|---|---|
|
Status of Tissue Iron Store
serum ferritin (Baseline)
|
32.1 µg/L
Standard Deviation 2.5
|
34.4 µg/L
Standard Deviation 2.6
|
25.9 µg/L
Standard Deviation 3.1
|
31.1 µg/L
Standard Deviation 2.5
|
|
Status of Tissue Iron Store
serum ferritin (Midline)
|
34.5 µg/L
Standard Deviation 1.9
|
32.1 µg/L
Standard Deviation 2.3
|
32.3 µg/L
Standard Deviation 2.1
|
26.5 µg/L
Standard Deviation 2.3
|
|
Status of Tissue Iron Store
serum ferritin (Endline)
|
39.6 µg/L
Standard Deviation 2.1
|
35.0 µg/L
Standard Deviation 2.5
|
35.4 µg/L
Standard Deviation 2.4
|
28.2 µg/L
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: at week 0, week 6 and week12Population: Per Protocol analysis
Cellular Iron deficiency status is also measured by serum transferrin receptor
Outcome measures
| Measure |
Iron Group
n=94 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
|
Vitamin A Group
n=101 Participants
15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
|
Iron and Vitamin A Group
n=98 Participants
60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
|
Placebo Group
n=98 Participants
2.5 mg folic acid + Vitamin A placebo
|
|---|---|---|---|---|
|
Status of Cellular Iron Deficiency
serum transferrin receptor (Baseline)
|
7.09 mg/L
Standard Deviation 1.52
|
6.56 mg/L
Standard Deviation 1.42
|
7.16 mg/L
Standard Deviation 1.59
|
6.74 mg/L
Standard Deviation 1.50
|
|
Status of Cellular Iron Deficiency
serum transferrin receptor (Midline)
|
6.69 mg/L
Standard Deviation 1.51
|
6.39 mg/L
Standard Deviation 1.41
|
6.73 mg/L
Standard Deviation 1.53
|
6.59 mg/L
Standard Deviation 1.53
|
|
Status of Cellular Iron Deficiency
serum transferrin receptor (Endline)
|
6.44 mg/L
Standard Deviation 1.55
|
6.27 mg/L
Standard Deviation 1.44
|
6.24 mg/L
Standard Deviation 1.43
|
6.61 mg/L
Standard Deviation 1.54
|
Adverse Events
Iron Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitamin A Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iron and Vitamin A Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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
Dr. Min Kyaw Htet, Township Health Officer, Ministry of Health, Myanmar
South East Asia Ministers of Education Organization, Regional Center for Food and Nutrition
Phone: +62-857-27262672
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place