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. 2021 Mar 5;17(1):e1141. doi: 10.1002/cl2.1141
Methods A randomized, double‐masked trial conducted in Nepal
Participants Inclusion criteria: Infants 5 months of age or younger
Exclusion criteria: Infants >5 months of age
Total number randomized in the intervention group: 5832
Total number randomized in the control group: 6086
Interventions Intervention:
  • 15,000 RE (50,000 IU) vitamin A administered orally in approximately 3 drops of oil for neonates (<1 month old)

  • 30,000 RE (100,000 IU) vitamin A administered orally in approximately 6 drops of oil for infants ages 1–5 months old

Control:
  • 75 RE (250 IU) administered orally for neonates (<1 month old)

  • 150 RE (500 IU) administered orally for infants ages 1–5 months old

Common intervention given to all groups: Approximately 3.3 IU vitamin E per drop of oil
Outcomes Primary outcome: Infant mortality, all‐cause mortality
Other outcomes: Malnutrition, ALRI, diarrhea or dysentery, whooping cough, meningitis, sudden death
Notes All analyses were completed on an intent‐to‐treat basis