BACKGROUND:Prophylactic vitamin A supplementation (VAS) reduces mortality and may reduce morbidity associated with diarrhea in children >6 months of age. Rotavirus is the most common cause of acute dehydrating diarrhea among children worldwide. METHODS: In a randomized placebo-controlled study of 50,000 IU of vitamin A versus placebo given with bacille Calmette-Guérin vaccine at birth, 287 infants were followed up with weekly interviews and stool sample obtainment to test the hypothesis that VAS reduced the risk of rotavirus infection. RESULTS:VAS was associated with increased risk of rotavirus infection and diarrhea (incidence rate ratio [IRR] of infection, 1.72 [95% confidence interval (CI), 1.04-2.85]; IRR of diarrhea, 3.74 [95% CI, 1.40-9.98]) among children <6 months of age. There was no effect in older children. VAS had a beneficial effect on nonrotavirus diarrhea in boys <6 months of age (IRR, 0.51; 95% CI, 0.27-0.95) and a detrimental effect in girls >6 months of age (IRR, 1.84; 95% CI, 0.96-3.55). CONCLUSION:VAS at birth did not reduce rotavirus morbidity. The effect of VAS on nonrotavirus diarrhea may differ by sex, being more beneficial in boys. Clinical trials registration. NCT00168597 .
RCT Entities:
BACKGROUND: Prophylactic vitamin A supplementation (VAS) reduces mortality and may reduce morbidity associated with diarrhea in children >6 months of age. Rotavirus is the most common cause of acute dehydrating diarrhea among children worldwide. METHODS: In a randomized placebo-controlled study of 50,000 IU of vitamin A versus placebo given with bacille Calmette-Guérin vaccine at birth, 287 infants were followed up with weekly interviews and stool sample obtainment to test the hypothesis that VAS reduced the risk of rotavirus infection. RESULTS:VAS was associated with increased risk of rotavirus infection and diarrhea (incidence rate ratio [IRR] of infection, 1.72 [95% confidence interval (CI), 1.04-2.85]; IRR of diarrhea, 3.74 [95% CI, 1.40-9.98]) among children <6 months of age. There was no effect in older children. VAS had a beneficial effect on nonrotavirus diarrhea in boys <6 months of age (IRR, 0.51; 95% CI, 0.27-0.95) and a detrimental effect in girls >6 months of age (IRR, 1.84; 95% CI, 0.96-3.55). CONCLUSION:VAS at birth did not reduce rotavirus morbidity. The effect of VAS on nonrotavirus diarrhea may differ by sex, being more beneficial in boys. Clinical trials registration. NCT00168597 .
Authors: Daniel J Raiten; Fayrouz A Sakr Ashour; A Catharine Ross; Simin N Meydani; Harry D Dawson; Charles B Stephensen; Bernard J Brabin; Parminder S Suchdev; Ben van Ommen Journal: J Nutr Date: 2015-04-01 Impact factor: 4.798
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