Methods
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Randomized, placebo‐controlled, 2‐by‐2 factorial design trial was conducted in Zimbabwe |
Participants
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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 |
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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 |
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Total number randomized in the intervention group: |
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Aa: 3529
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Ap: 3529
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Pa: 3530
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Total number randomized in the control group: Pp: 3522 |
Interventions
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Intervention: |
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Mothers received 400,000 IU vitamin A (as retinyl palmitate) and infants received 50,000 IU vitamin A (Aa group)
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Mothers received 400,000 IU vitamin A and infants received placebo (Ap group)
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Mothers received placebo and infants received 50,000 IU vitamin A (Pa group)
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Control: Both mothers and infants received placebo (Pp group) |
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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
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Primary outcome: Infant mortality |
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Other outcomes: None |
Notes
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