Methods
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Randomized placebo controlled trial conducted in Guinea‐Bissau |
Participants
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Inclusion Criteria: Weight at least 2500 g at presentation and no signs of overt illness or malformations |
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Exclusion Criteria: Weight <2500 g at presentation and/or signs of overt illness and/or malformations. Also, infants who died in the maternity ward before the vaccination team could arrive |
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Total number randomized to the intervention group: 2145 |
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Total number randomized to the control group: 2200 |
Interventions
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Intervention: 50,000 IU vitamin A intradermally |
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Control: 0.5 ml vegetable oil intradermally |
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Common intervention given to all groups: 10 IU vitamin E intradermally |
Outcomes
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Primary outcomes: Overall mortality |
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Other outcomes: Bulging fontanelles, vomiting, irritability, infections, fever, skin problems, and healthcare contacts |
Notes
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Vitamin A supplementation appeared to benefit boys but was harmful to girls |