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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome: All-cause, Pregnancy-related Mortality [ Time Frame: Deaths during pregnancy through 12 weeks postpartum ]

Mortality evaluated on intent-to-treat basis


Original Primary Outcome:

  • All-cause pregnancy-related maternal mortality
  • Perinatal and neonatal mortality
  • Three-month infant mortality


Current Secondary Outcome:

  • All-cause 3-month Infant Mortality [ Time Frame: Deaths through the 1st 12 weeks of life ]
  • Maternal Morbidity, Including Obstetric Complications [ Time Frame: through the 1st 24 weeks following termination of pregnancy ]
  • Gestational Age at Birth [ Time Frame: 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 ]
  • Infant Morbidity Through 3 Months of Age [ Time Frame: 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) ]
  • 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) ]


Original Secondary Outcome:

  • Maternal Morbidity, Including Obstetric Complications
  • Gestational Age at Birth
  • Fetal and postnatal growth through three months of age
  • Infant morbidity through three months of age
  • Maternal and infant nutritional status


Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: September 12, 2005
Date Started: August 2001
Date Completion:
Last Updated: March 5, 2012
Last Verified: March 2012