Antenatal Micronutrient Supplementation and Infant Survival — JiVitA-3  

Preterm Birth Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Birth Weight
• Infant Death
• Infant Mortality
• Low Birth Weight
• Neonatal Mortality
• Perinatal Death
• Perinatal Mortality
• Premature Birth
• Preterm Birth

• NCT number: NCT00860470
• Study type: Interventional
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Completion date: September 2012