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


METHODS
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.
Idindili
Boniphace
B
Ifakara Health Research and Development Centre, Ifakara, Tanzania.
Masanja
Honarati
H
Urassa
Honorathy
H
Bunini
Wilbert
W
van Jaarsveld
Paul
P
Aponte
John J
JJ
Kahigwa
Elizeus
E
Mshinda
Hassan
H
Ross
David
D
Schellenberg
David M
DM
D000328:Adult; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004355:Drug Stability; D005260:Female; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D008297:Male; D008895:Milk, Human / Q000737:chemistry*; D009751:Nutritional Requirements; D009752:Nutritional Status; D049590:Postpartum Period; D012449:Safety; D013636:Tanzania; D016896:Treatment Outcome; D014801:Vitamin A / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D014802:Vitamin A Deficiency / Q000097:blood / Q000401:mortality / Q000517:prevention & control*; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood
D014815:Vitamins; D014801:Vitamin A