Published online July 1, 2008
PEDIATRICS Vol. 122 No. 1 July 2008, pp. e242-e250 (doi:10.1542/peds.2007-3448)
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ARTICLE

Newborn Vitamin A Supplementation Reduced Infant Mortality in Rural Bangladesh

Rolf D.W. Klemm, MPH, DrPHa, Alain B. Labrique, MSc, MHS, PhDa, Parul Christian, MPH, DrPHa, Mahbubur Rashid, MBBS, MSc, MBAb, Abu Ahmed Shamim, MScb, Joanne Katz, MS, ScDa, Alfred Sommer, MD, MHSa and Keith P. West, Jr, DrPH, MPH, RDa

a Center for Human Nutrition, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
b JiVitA Maternal and Infant Health and Nutrition Research Project, Rangpur, Bangladesh

OBJECTIVES. We assessed the effect of supplementing newborns with 50000 IU of vitamin A on all-cause infant mortality through 24 weeks of age.

PATIENTS AND METHODS. This was a community-based, double-masked, cluster-randomized, placebo-controlled trial conducted in 19 unions in rural northwest Bangladesh. The study was nested into and balanced across treatment arms of an ongoing placebo-controlled, weekly maternal vitamin A or β-carotene supplementation trial. Study-defined sectors (N = 596) were evenly randomized for newborns of participating mothers to receive a single, oral supplement of vitamin A (50000 IU) or placebo as droplets of oil squeezed from a gelatinous capsule. Mothers provided informed consent for newborn participation at ~28 weeks' gestation. After birth, typically at home (where >90% of births occurred), infants were supplemented and their vital status was followed through 24 weeks of age. The main outcome measure was mortality through 24 weeks of age.

RESULTS. We obtained maternal consent to dose 17116 live-born infants (99.8% of all eligible) among whom 15937 (93.1%) were visited to be supplemented <30 days after birth and for whom vital status at 24 weeks of age was known. Dosed infants (n = 15902 [99.8%]) received their study supplement at a median age of 7 hours. Relative to control subjects, the risk of death in vitamin A–supplemented infants was 0.85, reflecting a 15% reduction in all-cause mortality. Protective relative risks were indistinguishable by infant gender, gestational age, birth weight, age at dosing, maternal age, parity, or across the 3 treatment arms of the maternal supplementation trial.

CONCLUSIONS. Newborn vitamin A dosing improved infant survival through the first 6 months of life in Bangladesh. These results corroborate previous findings from studies in Indonesia and India and provide additional evidence that vitamin A supplementation shortly after birth can reduce infant mortality in South Asia.

Key Words: vitamin A • infant mortality • neonatal mortality • community trial • Bangladesh • supplementation

Abbreviations: IQR—interquartile range • DSMB—data safety and monitoring board • RR—relative risk • CI—confidence interval • GEE—generalized estimating equation • NEC—necrotizing enterocolitis

Accepted Feb 8, 2008.