Trial Outcomes & Findings for Antenatal Micronutrient Supplementation and Infant Survival (NCT NCT00860470)
NCT ID: NCT00860470
Last Updated: 2022-10-19
Results Overview
Infant Mortality to Age 6 months (180 days from birth)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44567 participants
Primary outcome timeframe
6-months post-birth
Results posted on
2022-10-19
Participant Flow
Enumeration of women began in December 2007, and active recruitment of pregnant women into the trail began in January 2008. Women were enrolled into the trial by community workers from the projects who visited them at home.
Participant milestones
| Measure |
Iron and Folate
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Overall Study
STARTED
|
22162
|
22405
|
|
Overall Study
COMPLETED
|
22114
|
22346
|
|
Overall Study
NOT COMPLETED
|
48
|
59
|
Reasons for withdrawal
| Measure |
Iron and Folate
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Overall Study
Death
|
6
|
10
|
|
Overall Study
Moved away
|
8
|
10
|
|
Overall Study
Lost to Follow-up
|
34
|
39
|
Baseline Characteristics
Antenatal Micronutrient Supplementation and Infant Survival
Baseline characteristics by cohort
| Measure |
Iron and Folate
n=22 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=22 Participants
Multiple micronutrient
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Total
n=44567 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 6.43 • n=93 Participants
|
24.4 years
STANDARD_DEVIATION 6.44 • n=4 Participants
|
24.3 years
STANDARD_DEVIATION 6.43 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22,162 Participants
n=93 Participants
|
22,405 Participants
n=4 Participants
|
44567 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Bangladeshi
|
22,162 participants
n=93 Participants
|
22,405 participants
n=4 Participants
|
44567 participants
n=27 Participants
|
|
Region of Enrollment
Bangladesh
|
22,162 participants
n=93 Participants
|
22,405 participants
n=4 Participants
|
44567 participants
n=27 Participants
|
|
Gestational Age in weeks
|
10.34 weeks
STANDARD_DEVIATION 4.7 • n=93 Participants
|
10.28 weeks
STANDARD_DEVIATION 4.7 • n=4 Participants
|
10.30 weeks
STANDARD_DEVIATION 4.7 • n=27 Participants
|
|
Literacy
Literate
|
12,816 participants
n=93 Participants
|
12,985 participants
n=4 Participants
|
25801 participants
n=27 Participants
|
|
Literacy
Illiterate
|
9,346 participants
n=93 Participants
|
9,420 participants
n=4 Participants
|
18766 participants
n=27 Participants
|
|
Parity
0
|
6,671 participants with reported data
n=93 Participants
|
6,647 participants with reported data
n=4 Participants
|
13318 participants with reported data
n=27 Participants
|
|
Parity
1-3
|
13,255 participants with reported data
n=93 Participants
|
13,520 participants with reported data
n=4 Participants
|
26775 participants with reported data
n=27 Participants
|
|
Parity
>=4
|
2,186 participants with reported data
n=93 Participants
|
2,194 participants with reported data
n=4 Participants
|
4380 participants with reported data
n=27 Participants
|
|
Previous Pregnancy Loss
|
4,974 participants
n=93 Participants
|
5,106 participants
n=4 Participants
|
10080 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6-months post-birthPopulation: Not all women recruited into the trial had pregnancies yielding live births. This represents all live births by arm.
Infant Mortality to Age 6 months (180 days from birth)
Outcome measures
| Measure |
Iron and Folate
n=14142 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=14374 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Infant Mortality Through 6 mo of Age
|
764 participants
|
741 participants
|
SECONDARY outcome
Timeframe: 1 month post-birthNeonatal Mortality (28 days of life)
Outcome measures
| Measure |
Iron and Folate
n=14142 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=14374 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Neonatal Mortality
|
625 participants
|
626 participants
|
SECONDARY outcome
Timeframe: 1-6 months post-birthRisk of Post-neonatal Mortality (29th -180th day of life)
Outcome measures
| Measure |
Iron and Folate
n=13517 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=13748 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Post-neonatal Mortality
|
139 participants
|
115 participants
|
SECONDARY outcome
Timeframe: 24 weeks gestation to deliveryStillbirth (born \>=24 weeks without breathing, crying, or moving limbs).
Outcome measures
| Measure |
Iron and Folate
n=14858 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=15022 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Still Birth Rates
|
716 participants
|
648 participants
|
SECONDARY outcome
Timeframe: Up to 37 weeks of gestationBeing born before 37 weeks of gestation
Outcome measures
| Measure |
Iron and Folate
n=13333 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=13475 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Preterm Birth
|
2912 participants
|
2510 participants
|
SECONDARY outcome
Timeframe: Up to 28 weeks of gestationBirth before 28 weeks gestation
Outcome measures
| Measure |
Iron and Folate
n=13333 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=13475 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Extremely Pre-term
|
136 participants
|
106 participants
|
SECONDARY outcome
Timeframe: Between 27 and 33 weeks of gestationBirth between 28 and 32 weeks of gestation
Outcome measures
| Measure |
Iron and Folate
n=13333 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=13475 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Very Pre-term
|
385 participants
|
291 participants
|
SECONDARY outcome
Timeframe: Between 31 and 38 weeks of gestationBirth between 32 and 37 weeks gestation
Outcome measures
| Measure |
Iron and Folate
n=13333 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=13475 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Moderate to Late Preterm
|
2391 participants
|
2113 participants
|
SECONDARY outcome
Timeframe: Measured at delivery/birthBirth weight below 2500g
Outcome measures
| Measure |
Iron and Folate
n=10530 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=10642 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Low Birth Weight
|
4809 participants
|
4275 participants
|
SECONDARY outcome
Timeframe: At delivery/birthSmall for Gestational Age defined as birth weight \<10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Outcome measures
| Measure |
Iron and Folate
n=10099 Participants
Iron (27 mg) and folic acid (600 ug)
Iron (27 mg) - folic acid (600 ug): Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
Multiple Micronutrient
n=10161 Participants
Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
|
|---|---|---|
|
Small for Gestation Age
|
6479 participants
|
6405 participants
|
Adverse Events
Iron (27 mg) and Folic Acid (600 ug)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple Micronutrient
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