Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial

Randomized, double-blind, placebo-controlled trial in newborn infants from Dar es Salaam and Morogoro regions of Tanzania. Eligible infants could feed orally and their families planned to remain in the study area for at least 6 months.

Newborns received a single oral capsule of vitamin A, 50,000 IU as retinol palmitate, within the first 3 days after birth. The comparator was a matching placebo capsule; the regimen was one dose only, given orally in the home or labour ward.

Neonatal vitamin A did not reduce mortality by 6 months. Deaths by 6 months were 407/15 428 in the vitamin A group versus 372/15 464 in the placebo group, with RR 1•10 (95% CI 0•95-1•26; p=0•193) and RD 2•32 (95% CI -1•17 to 5•82). Mortality was also similar at 28 days (RR 1•04, 95% CI 0•86-1•25) and 12 months (RR 1•04, 95% CI 0•93-1•17). The intervention was well tolerated, with no important excess of adverse events within 3 days, and no differential effect by sex.

Interpretation is limited to a single-dose neonatal intervention in newborns from specific Tanzanian regions who could feed orally and whose families planned to stay for follow-up. The packet does not report major design flaws, but the null primary result means the trial did not show benefit despite very large enrollment.