Maternal low-dose vitamin A or beta-carotene supplementation has no effecton fetal loss and early infant mortality: a randomized cluster trial in Nepal

Background: The effect of vitamin A supplementation on the survival of infa nts aged <6 mo is unclear. Because most infant deaths occur in the first fe w month of life, maternal supplementation may improve infant survival. Objectives: The objective was to assess the effect of maternal vitamin A or beta-carotene supplementation on fetal loss and survival of infants <6 mo of age. Design: Married women of reproductive age in 270 wards of Sarlahi district, Nepal, were eligible to participate. Wards were randomly assigned to have women receive weekly doses of 7000 mu g retinol equivalents as retinyl palm itate (vitamin A), 42 mg all-trans-beta-carotene, or placebo. Pregnancies w ere followed until miscarriage, stillbirth, maternal death, or live birth o f one or more infants, who were followed through 24 wk of age. Results: A total of 43 559 women were enrolled; 15 832 contributed 17 373 p regnancies and 15 987 live born infants to the trial. The rate of fetal los s was 92.0/1000 pregnancies in the placebo group, comparable with rates in the vitamin A and beta-carotene groups, which had relative risks of 1.06 (9 5% CI: 0.91, 1.25) and 1.03 (95% CI: 0.87, 1.19), respectively. The 24-wk m ortality rate was 70.8/1000 live births in the placebo group, comparable wi th rates in the vitamin A and beta-carotene groups, which had relative risk s of 1.05 (95% CI: 0.87, 1.25) and 1.03 (95% CI: 0.86, 1.22), respectively. Conclusions: Small weekly doses of vitamin A or beta-carotene given to wome n before conception, during pregnancy, and through 24 wk postpartum did not improve fetal or early infant survival in Nepal.