The effects of vitamin A supplementation on the morbidity of children born to HIV-infected women.

Double-blind, randomized trial in infants born to HIV-infected women at King Edward VIII Hospital in Durban, South Africa. The vitamin A arm enrolled 60 infants; the population was full-term and predominantly breastfed, with follow-up from 1 to 18 months of age.

The active regimen was oral vitamin A as retinyl palmitate, given at 1 and 3 months as 50,000 IU, at 6 and 9 months as 100,000 IU, and at 12 and 15 months as 200,000 IU. The capsules and drops were matched to placebo; follow-up continued to 18 months.

Vitamin A supplementation reduced overall morbidity through 18 months of age, with the clearest benefit for diarrhea-related outcomes. The odds ratio for all morbidity was 0.69 (0.48, 0.99), diarrhea was 0.71 (0.47, 1.08), diarrhea lasting 7 days was 0.62 (0.32, 1.20), and hospitalization for diarrhea was 0.23 (0.04, 1.20). Benefits were reported as larger among HIV-infected infants, while mortality was not reduced. Growth was not adversely affected; weight gain from 1 to 9 months was 4.42 kg in the vitamin A group versus 4.84 kg in the placebo group.

The vitamin A arm was small, with only 60 enrolled infants, and several outcome estimates had wide confidence intervals that crossed 1. The trial was conducted in one hospital in Durban among mostly Zulu, predominantly breastfed infants, which limits generalizability. There was no mortality benefit, and the setting was not broadly vitamin A deficient, so applicability to other populations may be limited.