Objective

To assess the impact of supplementing newborn infants with vitamin A on mortality at age 6 months.

Design

Community based, randomised, double blind, placebo controlled trial.

Setting

Two rural districts of Tamil Nadu, southern India.

Participants

11 619 newborn infants allocated 24 000 IU oral vitamin A or placebo on days 1 and 2 after delivery.

Main outcome measure

Primary outcome measure was mortality at age 6 months.

Results

Infants in the vitamin A group had a 22% reduction in total mortality (95% confidence interval 4% to 37%) compared with those in the placebo group. Vitamin A had an impact on mortality between two weeks and three months after treatment, with no additional impact after three months.

Conclusion

Supplementing newborn infants with vitamin A can significantly reduce early infant mortality.