Antenatal Micronutrient Supplementation and Infant Survival

Johns Hopkins Bloomberg School of Public Health44,567 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

44,567

Conditions

Infant Mortality Preterm Birth Low Birth Weight Neonatal Mortality Perinatal Mortality

Interventions

Iron (27 mg) - folic acid (600 ug)DIETARY_SUPPLEMENT

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 micronutrientDIETARY_SUPPLEMENT

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.

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins School of Public Health

Baltimore, Maryland, United States

JiVitA Project Office

Rangpur City, Gaibandha District, Bangladesh

Outcomes

Primary Outcomes

Infant Mortality Through 6 mo of Age

Infant Mortality to Age 6 months (180 days from birth)

Time frame: 6-months post-birth

Secondary Outcomes

Neonatal Mortality

Neonatal Mortality (28 days of life)

Time frame: 1 month post-birth

Post-neonatal Mortality

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

Time frame: 1-6 months post-birth

Still Birth Rates

Stillbirth (born \>=24 weeks without breathing, crying, or moving limbs).

Time frame: 24 weeks gestation to delivery

Preterm Birth

Being born before 37 weeks of gestation

Time frame: Up to 37 weeks of gestation

Extremely Pre-term

Birth before 28 weeks gestation

Time frame: Up to 28 weeks of gestation

Very Pre-term

Birth between 28 and 32 weeks of gestation

Time frame: Between 27 and 33 weeks of gestation

Moderate to Late Preterm

Birth between 32 and 37 weeks gestation

Time frame: Between 31 and 38 weeks of gestation

Low Birth Weight

Birth weight below 2500g

Data from ClinicalTrials.gov

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