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

Phase 3

Completed

Conditions: Vitamin A Deficiency
Maternal Mortality
Infant Mortality

Interventions: Dietary Supplement: Vitamin A or Beta-Carotene Supplements

Registration Number: NCT00198822

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 59666

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vitamin A or Beta-Carotene Supplements	Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
2	Vitamin A or Beta-Carotene Supplements	Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
3	Vitamin A or Beta-Carotene Supplements	Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy

Primary Outcome Measures

Name	Time	Method
All-cause, Pregnancy-related Mortality	Deaths during pregnancy through 12 weeks postpartum	Mortality evaluated on intent-to-treat basis

Secondary Outcome Measures

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

Trial Locations

Locations (3): Johns Hopkins School of Public Health
🇺🇸
Baltimore, Maryland, United States
JiVitA Bangladesh Project
🇧🇩
Rangpur, Rajshahi Division, Bangladesh
JiVitA Project Office
🇧🇩
Rangpur, Rangpur District, Bangladesh