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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Vitamin A Deficiency; Infant Mortality; Maternal Mortality

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00198822

GHS-A-00-03-00019-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59,666 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59,666 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Weekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy

Treatment:

Dietary Supplement: Vitamin A or Beta-Carotene Supplements

2

Experimental group

Description:

Weekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy

Treatment:

Dietary Supplement: Vitamin A or Beta-Carotene Supplements

3

Placebo Comparator group

Description:

Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy

Treatment:

Dietary Supplement: Vitamin A or Beta-Carotene Supplements