Two different doses of supplemental vitamin A did not affect mortality of normal-birth-weight neonates in Guinea-Bissau in a randomized controlled trial

Christine Stabell Benn, Birgitte R Diness, Ibraima Balde, Amabelia Rodrigues, Karen R Lausch, Cesario L Martins, Ane B Fisker, Peter Aaby

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

Whether neonatal vitamin A supplementation (NVAS) should be policy in areas with vitamin A deficiency is debated. We observed that a smaller dose of vitamin A may decrease mortality more than a larger dose and conducted a randomized, double-blind, placebo-controlled trial in Guinea-Bissau with the primary aim of comparing the effect of 50,000 with 25,000 IU neonatal vitamin A on infant mortality. The secondary aim was to study the effect of NVAS vs. placebo, including a combined analysis of NVAS trials. Between 2004 and 2007, normal-birth-weight neonates were randomly assigned in a 1:1:1 ratio to be administered 2 different doses of vitamin A (50,000 or 25,000 IU) or placebo. Infant mortality rates (MRs) were compared in Cox models providing MR ratios (MRRs). Among 6048 children enrolled, there were 160 deaths in 4125 person-years (MR = 39/1000). There was no difference in mortality between the 2 dosage groups: the MRR for 25,000 vs. 50,000 IU was 0.96 (95% CI: 0.67, 1.38). Neither dose of NVAS was associated with lower mortality than placebo (MRR = 1.28; 95% CI: 0.91, 1.81). In a combined analysis of the present trial and 2 previous NVAS trials in Guinea-Bissau, the effect of receiving NVAS (any dose) vs. placebo was 1.13 (95% CI: 0.94, 1.36) and differed significantly (P = 0.01) between boys (0.80; 95% CI: 0.58, 1.09) and girls (1.35; 95% CI: 1.04, 1.75). We could not confirm that a smaller dose of neonatal vitamin A reduces mortality more than a larger dose. We confirmed 2 other trials in Guinea-Bissau that showed no beneficial effect of NVAS. This trial was registered at clinicaltrials.gov as NCT00168610.

Original languageEnglish
JournalJournal of Nutrition
Volume144
Issue number9
Pages (from-to)1474-1479
ISSN0022-3166
DOIs
Publication statusPublished - 2014

Keywords

  • Birth Weight
  • Child, Preschool
  • Dietary Supplements
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Guinea-Bissau
  • Humans
  • Infant
  • Infant Mortality
  • Infant, Newborn
  • Male
  • Reference Values
  • Sex Factors
  • Vitamin A
  • Vitamins

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