Antenatal Micronutrient Supplementation and Infant Survival

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

Sponsors

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Collaborator: Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Mahidol University
Johns Hopkins University
Beximco Pharmaceuticals Ltd.
DSM Nutritional Products, Inc.

Source Johns Hopkins Bloomberg School of Public Health
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.

Overall Status Completed
Start Date 2008-01-01
Completion Date 2012-09-01
Primary Completion Date 2012-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Infant Mortality Through 6 mo of Age Dec 2014
Secondary Outcome
Measure Time Frame
Neonatal Mortality Dec 2014
Post-neonatal Mortality Dec 2014
Still Birth Rates December 2014
Preterm Birth December 2014
Extremely Pre-term December 2014
Very Pre-term December 2014
Moderate to Late Preterm December 2014
Low Birth Weight December 2014
Small for Gestation Age December 2014
Enrollment 44567
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Iron (27 mg) - folic acid (600 ug)

Description: 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.

Arm Group Label: 1

Other Name: iron-folate

Intervention Type: Dietary Supplement

Intervention Name: Multiple micronutrient

Description: 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.

Arm Group Label: 2

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

Gender:

Female

Minimum Age:

12 Years

Maximum Age:

45 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Location
Facility:
Johns Hopkins School of Public Health | Baltimore, Maryland, 21205, United States
JiVitA Project Office | Rangpur, Gaibandha District, Bangladesh
Location Countries

Bangladesh

United States

Verification Date

2015-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Johns Hopkins Bloomberg School of Public Health

Investigator Full Name: Keith P. West

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

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

Label: 2

Type: Experimental

Description: Multiple micronutrient

Acronym JiVitA-3
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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