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Effects of vitamin A or beta carotene supplementation on pregnancy-related mortality and infant mortality in rural Bangladesh : a cluster randomized trial . CONTEXT Maternal vitamin A deficiency is a public health concern in the developing world . Its prevention may improve maternal and infant survival . OBJECTIVE To assess efficacy of maternal vitamin A or beta carotene supplementation in reducing pregnancy-related and infant mortality . DESIGN , SETTING , AND PARTICIPANTS Cluster randomized , double-masked , placebo-controlled trial among pregnant women 13 to 45 years of age and their live-born infants to 12 weeks ( 84 days ) postpartum in rural northern Bangladesh between 2001 and 2007 . Interventions Five hundred ninety-six community clusters ( study sectors ) were randomized for pregnant women to receive weekly , from the first trimester through 12 weeks postpartum , 7000 μg of retinol equivalents as retinyl palmitate , 42 mg of all-trans beta carotene , or placebo . Married women ( n = 125,257 ) underwent 5-week surveillance for pregnancy , ascertained by a history of amenorrhea and confirmed by urine test . Blood samples were obtained from participants in 32 sectors ( 5 % ) for biochemical studies . MAIN OUTCOME MEASURES All-cause mortality of women related to pregnancy , stillbirth , and infant mortality to 12 weeks ( 84 days ) following pregnancy outcome . RESULTS Groups were comparable across risk factors . For the mortality outcomes , neither of the supplement group outcomes was significantly different from the placebo group outcomes . The numbers of deaths and all-cause , pregnancy-related mortality rates ( per 100,000 pregnancies ) were 41 and 206 ( 95 % confidence interval [ CI ] , 140-273 ) in the placebo group , 47 and 237 ( 95 % CI , 166-309 ) in the vitamin A group , and 50 and 250 ( 95 % CI , 177-323 ) in the beta carotene group . Relative risks for mortality in the vitamin A and beta carotene groups were 1.15 ( 95 % CI , 0.75-1.76 ) and 1.21 ( 95 % CI , 0.81-1.81 ) , respectively . In the placebo , vitamin A , and beta carotene groups the rates of stillbirth and infant mortality were 47.9 ( 95 % CI , 44.3-51.5 ) , 45.6 ( 95 % CI , 42.1-49.2 ) , and 51.8 ( 95 % CI , 48.0-55.6 ) per 1000 births and 68.1 ( 95 % CI , 63.7-72.5 ) , 65.0 ( 95 % CI , 60.7-69.4 ) , and 69.8 ( 95 % CI , 65.4-72.3 ) per 1000 live births , respectively . Vitamin A compared with either placebo or beta carotene supplementation increased plasma retinol concentrations by end of study ( 1.46 [ 95 % CI , 1.42-1.50 ] μmol/L vs 1.13 [ 95 % CI , 1.09-1.17 ] μmol/L and 1.18 [ 95 % CI , 1.14-1.22 ] μmol/L , respectively ; P < .001 ) and reduced , but did not eliminate , gestational night blindness ( 7.1 % for vitamin A vs 9.2 % for placebo and 8.9 % for beta carotene [ P < .001 for both ] ) . CONCLUSION Use of weekly vitamin A or beta carotene in pregnant women in Bangladesh , compared with placebo , did not reduce all-cause maternal , fetal , or infant mortality . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00198822 .
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Intervention_Pharmacological
vitamin A or beta carotene supplementation
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Intervention_Pharmacological
vitamin A
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Intervention_Pharmacological
beta carotene
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Intervention_Control
placebo-controlled
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Outcome_Mortality
pregnancy-related mortality and infant mortality
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Participant_Age
pregnant women 13 to 45 years of age and their live-born infants to 12 weeks ( 84 days ) postpartum in rural northern Bangladesh between 2001 and 2007 .