Methods
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A randomized, double‐masked trial conducted in Nepal |
Participants
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Inclusion criteria: Infants 5 months of age or younger |
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Exclusion criteria: Infants >5 months of age |
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Total number randomized in the intervention group: 5832 |
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Total number randomized in the control group: 6086 |
Interventions
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Intervention: |
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15,000 RE (50,000 IU) vitamin A administered orally in approximately 3 drops of oil for neonates (<1 month old)
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30,000 RE (100,000 IU) vitamin A administered orally in approximately 6 drops of oil for infants ages 1–5 months old
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Control: |
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Common intervention given to all groups: Approximately 3.3 IU vitamin E per drop of oil |
Outcomes
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Primary outcome: Infant mortality, all‐cause mortality |
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Other outcomes: Malnutrition, ALRI, diarrhea or dysentery, whooping cough, meningitis, sudden death |
Notes
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All analyses were completed on an intent‐to‐treat basis |