Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants.
What this study found
The higher-dose vitamin A regimen was safe but did not meaningfully improve vitamin A status or reduce morbidity compared with the lower-dose regimen. At 6 months, there were no significant differences in MRDR deficiency, serum retinol, or breast milk retinol; for example, MRDR 0.06 was 43% versus 47% (RR 0.91, 95% CI 0.76 to 1.09; P = 0.32) and serum retinol 0.70 μmol/L was 36% versus 41% (RR 0.89, 95% CI 0.73 to 1.09; P = 0.25). At 9 months, results remained null, including MRDR 0.06 at 41% versus 40% (RR 1.01, 95% CI 0.83 to 1.24; P = 0.91) and serum retinol 0.70 μmol/L at 29% versus 32%…
- Study & population
- Randomized controlled trial in newborn infants and their mothers in Ifakara, southern Tanzania, with vitamin A deficiency concerns.
- Intervention
- The high-dose regimen used oral vitamin A palmitate capsules for mothers and infants at routine vaccination visits: mothers received 200,000 IU at the infant's BCG visit and again at the first DPT/OPV visit, and infants received 50,000 IU at each of the 3 DPT/OPV visits.
- Key limitation
- The trial found no clear efficacy advantage despite a biologically plausible higher-dose strategy, and the source notes that some vitamin A capsules degraded, which could have affected delivered dose and implementation.
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Open PDFOriginal abstract
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 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. 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.