Antenatal Micronutrient Supplementation and Infant Survival

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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

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.

DIETARY_SUPPLEMENT

Multiple micronutrient

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.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Mahidol University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Beximco Pharmaceuticals Ltd.

  collaborator INDUSTRY

• DSM Nutritional Products, Inc.

  collaborator INDUSTRY

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Keith P West, Jr. · Johns Hopkins Bloomberg School of Public Health

• Parul Christian · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2012-09-30

Completion

2012-09-30

Countries

• United States
• Bangladesh

Study Locations