Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

Summary

The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.

Conditions

• Vitamin A Deficiency
• Maternal Mortality
• Infant Mortality

Interventions

DIETARY_SUPPLEMENT

Vitamin A or Beta-Carotene Supplements

weekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Canadian International Development Agency

  collaborator OTHER_GOV

• The Sight and Life Research Institute

  collaborator UNKNOWN

• Access Business Group

  collaborator INDUSTRY

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

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

• Parul Christian, Dr.P.H. · Johns Hopkins Bloomberg School of Public Health

• Rolf DW Klemm, Dr.P.H. · Johns Hopkins Bloomberg School of Public Health

• Mahbubur Rashid, MBBS, MSc · JiVitA Bangladesh Project

• Alain B Labrique, MSc · Johns Hopkins Bloomberg School of Public Health

• Alfred Sommer, M.D. · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-08-31

Primary Completion

2007-01-31

Completion

2008-03-31

Countries

• United States
• Bangladesh

Study Locations