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

March 5, 2012 updated by: Keith P. West, Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. The present trial is testing the efficacy of the same supplements from ~9 weeks' gestation to 12 weeks postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19 rural unions, covering an area of ~750 sq km with a population of ~580,000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; ~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. Newly married women are prospectively enlisted for pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are recorded weekly through 3 months postpartum. Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. At 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. An additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. A ~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.

Study Type

Interventional

Enrollment (Actual)

59666

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Rajshahi Division
      • Rangpur, Rajshahi Division, Bangladesh
        • JiVitA Bangladesh Project
    • Rangpur District
      • Rangpur, Rangpur District, Bangladesh, 5400
        • JiVitA Project Office
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Married women of reproductive age
  • First pregnancy during time period of trial

Exclusion Criteria:

  • Premenarchial girls
  • Married women with a previous pregnancy enrolled into the trial
  • Previously married women who have moved into the study area
  • Single women (never married, widowers)
  • Women who are sterilized (or whose husbands are sterilized)
  • Menopausal women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
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
EXPERIMENTAL: 2
Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
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
PLACEBO_COMPARATOR: 3
Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause, Pregnancy-related Mortality
Time Frame: Deaths during pregnancy through 12 weeks postpartum
Mortality evaluated on intent-to-treat basis
Deaths during pregnancy through 12 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause 3-month Infant Mortality
Time Frame: Deaths through the 1st 12 weeks of life
Deaths through the 1st 12 weeks of life
Maternal Morbidity, Including Obstetric Complications
Time Frame: through the 1st 24 weeks following termination of pregnancy
through the 1st 24 weeks following termination of pregnancy
Gestational Age at Birth
Time Frame: within 24 weeks after birth
within 24 weeks after birth
Fetal Growth and Postnatal Infant Growth Through Three Months of Age
Time Frame: through the 1st 12 weeks after birth
through the 1st 12 weeks after birth
Infant Morbidity Through 3 Months of Age
Time Frame: within 24 weeks after birth
within 24 weeks after birth
Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)
Time Frame: Third trimester of pregnancy (about the 32nd week of gesatation)
Third trimester of pregnancy (about the 32nd week of gesatation)
Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)
Time Frame: Third trimester of pregnancy (about the 32nd week of gestation)
Third trimester of pregnancy (about the 32nd week of gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Access Business Group
Canadian International Development Agency
The Sight and Life Research Institute

Investigators

  • Principal Investigator: Keith P West, Jr., Dr.P.H., Johns Hopkins Bloomberg School of Public Health
  • Study Director: Parul Christian, Dr.P.H., Johns Hopkins Bloomberg School of Public Health
  • Study Director: Rolf DW Klemm, Dr.P.H., Johns Hopkins Bloomberg School of Public Health
  • Study Director: Mahbubur Rashid, MBBS, MSc, JiVitA Bangladesh Project
  • Study Director: Alain B Labrique, MSc, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHS-A-00-03-00019-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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