Antenatal Micronutrient Supplementation and Infant Survival

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh

Conditions
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Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality, Perinatal Mortality

Intervention / Treatment
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* Dietary Supplement: Iron (27 mg) - folic acid (600 ug)
* Dietary Supplement: Multiple micronutrient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Iron (27 mg) and folic acid (600 ug) | Dietary Supplement: Iron (27 mg) - folic acid (600 ug)<br>* 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.<br>* Other names: iron-folate;|
| Experimental: 2<br>Multiple micronutrient | Dietary Supplement: Multiple micronutrient<br>* 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.<br>* Other names: antenatal micronutrient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Mortality Through 6 mo of Age | Infant Mortality to Age 6 months (180 days from birth) | 6-months post-birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Mortality | Neonatal Mortality (28 days of life) | 1 month post-birth | 
| Post-neonatal Mortality | Risk of Post-neonatal Mortality (29th -180th day of life) | 1-6 months post-birth | 
| Still Birth Rates | Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). | 24 weeks gestation to delivery | 
| Preterm Birth | Being born before 37 weeks of gestation | Up to 37 weeks of gestation | 
| Extremely Pre-term | Birth before 28 weeks gestation | Up to 28 weeks of gestation | 
| Very Pre-term | Birth between 28 and 32 weeks of gestation | Between 27 and 33 weeks of gestation | 
| Moderate to Late Preterm | Birth between 32 and 37 weeks gestation | Between 31 and 38 weeks of gestation | 
| Low Birth Weight | Birth weight below 2500g | Measured at delivery/birth | 
| 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). | At delivery/birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micronutrients, deficiency, pregnancy, birth outcomes, infant mortality, neonatal mortality, malnutrition, antenatal