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. 2021 Mar 5;17(1):e1141. doi: 10.1002/cl2.1141
Methods Randomized, placebo‐controlled, 2‐by‐2 factorial design trial was conducted in Zimbabwe
Participants Inclusion criteria: Neither the mother nor the infant had an acutely life‐threatening condition, the infant was a singleton with a birth weight of >1500 g, and the mother planned to stay in the region after delivery
Exclusion criteria: Either the mother and/or the infant had an acutely life‐threatening condition, the infant was not a singleton or had a birth weight of <1500 g, and the mother did not plan to stay in the region after delivery
Total number randomized in the intervention group:
  • Aa: 3529

  • Ap: 3529

  • Pa: 3530

Total number randomized in the control group: Pp: 3522
Interventions Intervention:
  • Mothers received 400,000 IU vitamin A (as retinyl palmitate) and infants received 50,000 IU vitamin A (Aa group)

  • Mothers received 400,000 IU vitamin A and infants received placebo (Ap group)

  • Mothers received placebo and infants received 50,000 IU vitamin A (Pa group)

Control: Both mothers and infants received placebo (Pp group)
Common intervention given to all groups: Soy oil base with vitamin E as a preservative (50 IU per maternal capsule; 10 IU per infant capsule)
Outcomes Primary outcome: Infant mortality
Other outcomes: None
Notes