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ORIGINAL RESEARCH COMMUNICATION |
1 From the Ifakara Health Research and Development Centre, Ifakara, Tanzania (BI, HM, HU, EK, HM, and DMS); the St Francis Designated District Hospital, Ministry of Health, Ifakara, Tanzania (WB); the Nutritional Intervention Research Unit, Medical Research Council, Parow, Republic of South Africa (PvJ); the Hospital Clinic Center for International Health, University of Barcelona, Barcelona, Spain (JJA and DMS); the Manhiça Health Research Center, Manhiça, Mozambique (JJA); and the London School of Hygiene & Tropical Medicine, London, United Kingdom (DR and DMS)
Background: Vitamin A supplementation reduces morbidity and mortality in children living in areas endemic for vitamin A deficiency. Routine vitamin A supplementation usually starts only at age 9 mo, but high rates of illness and mortality are seen in the first months of life.
Objective: The objective of the study was to evaluate the safety and efficacy of vitamin A supplementation at the same time as routine vaccination in infants aged 1–3 mo.
Design: We recruited 780 newborn infants and their mothers to a randomized double-blind controlled trial in Ifakara in southern Tanzania. In one group, mothers received 60 000 µg vitamin A palmitate shortly after delivery, and their infants received 7500 µg at the same time as vaccinations given at 
1, 2, and 3 mo of age. In the other group, mothers received a second 60 000-µg dose when their infant was aged 1 mo, and their infants received 15 000 µg at the same time as the routine vaccinations. VAD was defined as a modified relative dose-response test result of 
0.060.
Results: High-dose vitamin A supplementation was well tolerated. The relative risk of VAD at 6 mo in the high-dose group compared with the lower dose group was 0.91 (95% CI: 0.76, 1.09; P = 0.32). Serum retinol and incidence of illness did not differ significantly between the 2 groups. Some vitamin A capsules degraded toward the end of the study.
Conclusions: Doubling the doses of vitamin A to mothers and their young infants is safe but unlikely to reduce short-term morbidity or to substantially enhance the biochemical vitamin A status of infants at age 6 mo. The stability of vitamin A capsules merits further investigation.
Key Words: Vitamin A • supplementation • safety • efficacy • Tanzania • infants
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