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. 2021 Mar 5;17(1):e1141. doi: 10.1002/cl2.1141
Methods Randomized, double‐blind, placebo‐controlled trial conducted in India
Participants Inclusion criteria: Livebirths born in the study area
Exclusion criteria: Died before screening, serious illness, and/or were admitted into the intensive care unit
Total number randomized in the intervention group: 22,493
Total number randomized in the control group: 22,491
Interventions Intervention: 50,000 IU vitamin A plus vitamin E 9.5–12.6 IU
Control: Placebo (vitamin E 9.5–12.6 IU)
Common intervention given to all groups: Vitamin E 9.5–12.6 IU
Outcomes Primary outcome: Infant mortality from supplementation to 6 months
Other outcomes: Neonatal mortality, mortality between supplementation and 12 months of age, infant hospital admission one or more times due to any illness between supplementation and 6 months of age, potential adverse events in the 3‐day period following supplementation, and vitamin A status in a sub‐sample of infants at 2 weeks and 3 months of age
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