1517 ISSN 0269-9370 © 1999 Lippincott Williams & Wilkins Randomized trial testing the effect of vitamin A supplementation on pregnancy outcomes and early mother-to-child HIV-1 transmission in Durban, South Africa Anna Coutsoudis, Kubendran Pillay, Elizabeth Spooner, Louise Kuhn a and Hoosen M. Coovadia for the South African Vitamin A Study Group b Objective: Poor vitamin A status has been associated with a higher risk for mother-to- child transmission of HIV-1 and there is contradictory evidence on the impact of vitamin A on perinatal outcome. We therefore assessed the effect of vitamin A supplementation to mothers on birth outcome and mother-to-child transmission of HIV-1. Design and methods: In Durban, South Africa 728 pregnant HIV infected women received either vitamin A (368) or placebo (360) in a randomized, double-blind trial. The vitamin A treatment consisted of a daily dose of 5000 IU retinyl palmitate and 30 mg β-carotene during the third trimester of pregnancy and 200 000 IU retinyl palmitate at delivery. HIV infection results were available on 632 children who were included in the Kaplan–Meier transmission analysis. Results are reported on mother- to-child transmission rates up to 3 months of age. Results: There was no difference in the risk of HIV infection by 3 months of age between the vitamin A [20.3%; 95% confidence interval (CI), 15.7–24.9] and placebo groups (22.3%; 95% CI, 17.5–27.1), nor were there differences in foetal or infant mortality rates between the two groups. Women receiving vitamin A supplement were, however, less likely to have a preterm delivery (11.4% in the vitamin A and 17.4% in the placebo group; P = 0.03) and among the 80 preterm deliveries, those assigned to the vitamin A group were less likely to be infected (17.9%; 95% CI, 3.5–32.2) than those assigned to the placebo group (33.8%; 95% CI, 19.8–47.8). Conclusion: Vitamin A supplementation, a low-cost intervention, does not appear to be effective in reducing overall mother-to-child transmission of HIV; however, its potential for reducing the incidence of preterm births, and the risk of mother-to- child transmission of HIV in these infants needs further investigation. © 1999 Lippincott Williams & Wilkins AIDS 1999, 13:1517–1524 Keywords: vitamin A, mother-to-child transmission of HIV-1 From the Department of Paediatrics and Child Health, University of Natal and Africa Centre for Population Studies and Reproductive Health, and the a Gertrude H. Sergievsky Center, Columbia University, New York. b See Appendix. Sponsorship: Funded in part by grants from the AIDS Directorate, National Department of Health, South Africa; South African Medical Research Council; University of Natal Research Fund; Opportunities for Micronutrient Initiatives/USAID and International Atomic Energy Agency (Vienna). Note: Vitamin A and placebo were supplied by Roche, South Africa and capsules were packaged by Hersol Laboratories, South Africa. Correspondence to A. Coutsoudis, Department of Paediatrics and Child Health, University of Natal, Private Bag 7, Congella 4013, South Africa (no reprints available). Received: 22 February 1999; revised: 7 May 1999; accepted: 12 May 1999.