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Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants.

Idindili, B., Masanja, H., Urassa, H., Bunini, W., van Jaarsveld, P., Aponte, J. J., Kahigwa, E., Mshinda, H., Ross, D. and Schellenberg, D. M. (2007) Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants. The American journal of clinical nutrition, 85 (5). pp. 1312-1319. ISSN 0002-9165

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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.


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.


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 microg vitamin A palmitate shortly after delivery, and their infants received 7500 microg at the same time as vaccinations given at approximately 1, 2, and 3 mo of age. In the other group, mothers received a second 60,000-microg dose when their infant was aged 1 mo, and their infants received 15,000 microg at the same time as the routine vaccinations. VAD was defined as a modified relative dose-response test result of >or=0.060.


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.


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.

Item Type: Article
Keywords: Vitamin A, supplementation, safety, mortality, morbidity Tanzania, infants, children
Subjects: Nutrition & food security > Undernutrition
Divisions: Ifakara Health Institute > Biomedical
Depositing User: Mr Joseph Madata
Date Deposited: 18 Sep 2012 09:42
Last Modified: 18 Sep 2012 09:42

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