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 beta-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 approximately 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.
RCT Entities:
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 beta-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 approximately 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.
Authors: Alison D Gernand; Parul Christian; Kerry J Schulze; Saijuddin Shaikh; Alain B Labrique; Abu Ahmed Shamim; Keith P West Journal: J Nutr Date: 2012-04-25 Impact factor: 4.798
Authors: Alison D Gernand; Parul Christian; Rina Rani Paul; Saijuddin Shaikh; Alain B Labrique; Kerry J Schulze; Abu Ahmed Shamim; Keith P West Journal: J Nutr Date: 2012-09-18 Impact factor: 4.798
Authors: Fernando C Barros; Zulfiqar Ahmed Bhutta; Maneesh Batra; Thomas N Hansen; Cesar G Victora; Craig E Rubens Journal: BMC Pregnancy Childbirth Date: 2010-02-23 Impact factor: 3.007
Authors: Maria W Merritt; Alain B Labrique; Joanne Katz; Mahbubur Rashid; Keith P West; Joan Pettit Journal: PLoS Med Date: 2010-10-05 Impact factor: 11.069
Authors: Rashidul Haque; Tanvir Ahmed; M A Wahed; Dinesh Mondal; A S M Hamidur Rahman; M John Albert Journal: J Health Popul Nutr Date: 2010-06 Impact factor: 2.000