Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Infant Mortality
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Enrollment
- 44567
- Locations
- 2
- Primary Endpoint
- Infant Mortality Through 6 mo of Age
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Infant Mortality Through 6 mo of Age
Time Frame: 6-months post-birth
Infant Mortality to Age 6 months (180 days from birth)
Secondary Outcomes
- Very Pre-term(Between 27 and 33 weeks of gestation)
- Post-neonatal Mortality(1-6 months post-birth)
- Neonatal Mortality(1 month post-birth)
- Preterm Birth(Up to 37 weeks of gestation)
- Small for Gestation Age(At delivery/birth)
- Extremely Pre-term(Up to 28 weeks of gestation)
- Moderate to Late Preterm(Between 31 and 38 weeks of gestation)
- Low Birth Weight(Measured at delivery/birth)
- Still Birth Rates(24 weeks gestation to delivery)