Title

Antenatal Micronutrient Supplementation and Infant Survival
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    iron folic acid ...
  • Study Participants

    44567
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.
Study Started
Jan 31
2008
Primary Completion
Sep 30
2012
Study Completion
Sep 30
2012
Results Posted
May 27
2015
Estimate
Last Update
May 27
2015
Estimate

Dietary Supplement 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.

  • Other names: iron-folate

Dietary Supplement 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.

  • Other names: one-a-day multivitamin, antenatal micronutrient

1 Active Comparator

Iron (27 mg) and folic acid (600 ug)

2 Experimental

Multiple micronutrient

Criteria

Inclusion Criteria:

Pregnant and consents to participate

Exclusion Criteria:

Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

Summary

Iron (27 mg) and Folic Acid (600 ug)

Multiple Micronutrient

All Events

Event Type Organ System Event Term

Infant Mortality Through 6 mo of Age

Risk of Infant Mortality to Age 6 months (180 days)

Iron and Folate

764.0
participants

Multiple Micronutrient

741.0
participants

Neonatal Mortality

Risk of neonatal Mortality (28 days of life)

Iron and Folate

625.0
participants

Multiple Micronutrient

626.0
participants

Post-neonatal Mortality

Risk of Post-neonatal Mortality (29th -180th day of life)

Iron and Folate

139.0
participants

Multiple Micronutrient

115.0
participants

Still Birth Rates

Risk of Still birth

Iron and Folate

716.0
participants

Multiple Micronutrient

648.0
participants

Preterm Birth

Risk of being born before 37 weeks of gestation

Iron and Folate

2912.0
participants

Multiple Micronutrient

2510.0
participants

Extremely Pre-term

Risk of birth before 28 weeks gestation

Iron and Folate

136.0
participants

Multiple Micronutrient

106.0
participants

Very Pre-term

Risk of birth between 28 and 32 weeks of gestation

Iron and Folate

385.0
participants

Multiple Micronutrient

291.0
participants

Moderate to Late Preterm

Risk of birth between 32 and 37 weeks gestation

Iron and Folate

2391.0
participants

Multiple Micronutrient

2113.0
participants

Low Birth Weight

Birth weight below 2500g

Iron and Folate

4809.0
participants

Multiple Micronutrient

4275.0
participants

Small for Gestation Age

Small 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).

Iron and Folate

6479.0
participants

Multiple Micronutrient

6405.0
participants

Total

44567
Participants

Age, Continuous

24.3
years (Mean)
Standard Deviation: 6.43

Gestational Age in weeks

10.30
weeks (Mean)
Standard Deviation: 4.7

Previous Pregnancy Loss

10080
participants

Gender

Literacy

Parity

Race/Ethnicity, Customized

Region of Enrollment

Overall Study

Iron and Folate

Multiple Micronutrient

Drop/Withdrawal Reasons

Iron and Folate

Multiple Micronutrient