Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Condition: Vitamin A Deficiency; Maternal Mortality; Infant Mortality
MeSH terms: Night Blindness; Maternal Death; Vitamin A Deficiency; Infant Death
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Vitamin A or Beta-Carotene Supplements
Intervention type(s): Dietary Supplement
Intervention description(s): 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
Intervention MeSH terms: Vitamin A; Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Maternal mortality; Infant mortality; Vitamin A; Beta-carotene; Micronutrients; Bangladesh; Neonatal mortality