Methods
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Randomized, double‐blind, placebo‐controlled trial conducted in India |
Participants
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Inclusion criteria: Livebirths born in the study area |
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Exclusion criteria: Died before screening, serious illness, and/or were admitted into the intensive care unit |
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Total number randomized in the intervention group: 22,493 |
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Total number randomized in the control group: 22,491 |
Interventions
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Intervention: 50,000 IU vitamin A plus vitamin E 9.5–12.6 IU |
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Control: Placebo (vitamin E 9.5–12.6 IU) |
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Common intervention given to all groups: Vitamin E 9.5–12.6 IU |
Outcomes
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Primary outcome: Infant mortality from supplementation to 6 months |
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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 |
Notes
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