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Maternal low-dose vitamin A or ß-carotene supplementation has no effect on fetal loss and early infant mortality: a randomized cluster trial in Nepal^1,2,3,4

¹ From the Department of International Health, the Center for Human Nutrition, the Sight and Life Institute, and the Dean's Office, Johns Hopkins School of Hygiene and Public Health, Baltimore, and the Nepal Nutrition Intervention Project Sarlahi and Tribhuvan University, Kathmandu, Nepal.

Background: The effect of vitamin A supplementation on the survival of infants aged <6 mo is unclear. Because most infant deaths occur in the first few month of life, maternal supplementation may improve infant survival.

Objectives: The objective was to assess the effect of maternal vitamin A or ß-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 µg retinol equivalents as retinyl palmitate (vitamin A), 42 mg all-trans-ß-carotene, or placebo. Pregnancies were followed until miscarriage, stillbirth, maternal death, or live birth of one or more infants, who were followed through 24 wk of age.

Results: A total of 43559 women were enrolled; 15832 contributed 17373 pregnancies and 15987 live born infants to the trial. The rate of fetal loss was 92.0/1000 pregnancies in the placebo group, comparable with rates in the vitamin A and ß-carotene groups, which had relative risks of 1.06 (95% CI: 0.91, 1.25) and 1.03 (95% CI: 0.87, 1.19), respectively. The 24-wk mortality rate was 70.8/1000 live births in the placebo group, comparable with rates in the vitamin A and ß-carotene groups, which had relative risks 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 ß-carotene given to women before conception, during pregnancy, and through 24 wk postpartum did not improve fetal or early infant survival in Nepal.

Key Words: Vitamin A • ß-carotene • infant mortality • child survival • fetal loss • maternal supplementation • Nepal • the Nepal Nutrition Intervention Project-Sarlahi Study Group

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