title: Randomized controlled safety and efficacy trial of 2 vitamin A supplementation schedules in Tanzanian infants.
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.
  
  
  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.
authors.affiliation: Ifakara Health Research and Development Centre, Ifakara, Tanzania.
authors.forename: Boniphace
authors.initials: B
authors.lastname: Idindili
authors.forename: Honarati
authors.initials: H
authors.lastname: Masanja
authors.forename: Honorathy
authors.initials: H
authors.lastname: Urassa
authors.forename: Wilbert
authors.initials: W
authors.lastname: Bunini
authors.forename: Paul
authors.initials: P
authors.lastname: van Jaarsveld
authors.forename: John J
authors.initials: JJ
authors.lastname: Aponte
authors.forename: Elizeus
authors.initials: E
authors.lastname: Kahigwa
authors.forename: Hassan
authors.initials: H
authors.lastname: Mshinda
authors.forename: David
authors.initials: D
authors.lastname: Ross
authors.forename: David M
authors.initials: DM
authors.lastname: Schellenberg
mesh_terms: 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
chemical_list: D014815:Vitamins; D014801:Vitamin A