title: The effect of neonatal vitamin A supplementation on morbidity and mortality at 12 months: a randomized trial.
abstract: : Neonatal vitamin A supplementation (NVAS) is an intervention hypothesized to reduce infant morbidity and mortality. The objective of this study was to assess the efficacy of neonatal vitamin A supplementation in reducing infant morbidity and mortality and assess potential sources of heterogeneity of the effect of NVAS.
  
  
  
  : We completed an individually randomized, double-blind, placebo-controlled trial in Tanzania. Infants were randomized within 3 days of birth to a single dose of vitamin A (50 000 IU) or placebo. We assessed infants at 1 and 3 days after supplementation, as well as 1, 3, 6 and 12 months after supplementation. We included all live births in the analysis and used relative risks (RR) and 95% confidence intervals (CI) to assess the risks of mortality and hospitalization by 12 months. We used general estimating equations to assess the incidence of morbidities during infancy.
  
  
  
  : A total of 31 999 infants were enrolled in the study between August 2010 and March 2013. At 12 months, vitamin A did not reduce all-cause infant mortality (RR 1.04; 95% CI 0.92-1.16), nor affect hospitalization (RR 1.09; 95% CI 0.97-1.22) or all-cause morbidity (RR 1.00; 95% CI 0.96-1.05). Postpartum maternal vitamin A supplementation modified the effect of neonatal vitamin A supplementation on mortality at 12 months ( P -value, test for interaction = 0.04). Among infants born to women who received a mega-dose of vitamin A after delivery, NVAS appeared to increase the risk of death (RR 1.12; 95% CI 0.98-1.29), whereas the risk of death among infants born to women who did not receive a mega-dose was reduced (RR 0.86; 95% CI 0.70-1.06). We noted no modification of the effect of NVAS by infant gender, birthweight or maternal HIV status.
  
  
  
  : NVAS did not affect the risk of death or incidence of common childhood morbidities. However, this study sheds light on potential sources of heterogeneity of the effect of neonatal vitamin A supplementation which should be further examined in a pooled analysis of all NVAS trials.
authors: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors: Emily R
authors: ER
authors: Smith
authors: Africa Academy of Public Health, Dar es Salaam, Tanzania.
authors: Alfa
authors: A
authors: Muhihi
authors: Africa Academy of Public Health, Dar es Salaam, Tanzania.
authors: Salum
authors: S
authors: Mshamu
authors: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors: Christopher R
authors: CR
authors: Sudfeld
authors: Africa Academy of Public Health, Dar es Salaam, Tanzania.|Department of Nutrition.
authors: Ramadhani Abdallah
authors: RA
authors: Noor
authors: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.|Africa Academy of Public Health, Dar es Salaam, Tanzania.|Department of Biostatistics.|Department of Epidemiology.
authors: Donna
authors: D
authors: Spiegelman
authors: Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
authors: Roger L
authors: RL
authors: Shapiro
authors: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors: Honorati
authors: H
authors: Masanja
authors: Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.|Department of Nutrition.|Department of Epidemiology.
authors: Wafaie
authors: W
authors: Fawzi
mesh_terms: D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008297:Male; D009017:Morbidity; D012044:Regression Analysis; D013636:Tanzania; D014801:Vitamin A / Q000008:administration & dosage*; D014802:Vitamin A Deficiency / Q000517:prevention & control; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D014815:Vitamins; D014801:Vitamin A
keywords: Neonatal vitamin A supplementation; Tanzania; hospitalization; infant mortality; morbidity