title: The effect of high-dose vitamin A supplementation given with bacille Calmette-Guérin vaccine at birth on infant rotavirus infection and diarrhea: a randomized prospective study from Guinea-Bissau.
abstract: BACKGROUND
  Prophylactic vitamin A supplementation (VAS) reduces mortality and may reduce morbidity associated with diarrhea in children >6 months of age. Rotavirus is the most common cause of acute dehydrating diarrhea among children worldwide.
  
  
  METHODS
  In a randomized placebo-controlled study of 50,000 IU of vitamin A versus placebo given with bacille Calmette-Guérin vaccine at birth, 287 infants were followed up with weekly interviews and stool sample obtainment to test the hypothesis that VAS reduced the risk of rotavirus infection.
  
  
  RESULTS
  VAS was associated with increased risk of rotavirus infection and diarrhea (incidence rate ratio [IRR] of infection, 1.72 [95% confidence interval (CI), 1.04-2.85]; IRR of diarrhea, 3.74 [95% CI, 1.40-9.98]) among children <6 months of age. There was no effect in older children. VAS had a beneficial effect on nonrotavirus diarrhea in boys <6 months of age (IRR, 0.51; 95% CI, 0.27-0.95) and a detrimental effect in girls >6 months of age (IRR, 1.84; 95% CI, 0.96-3.55).
  
  
  CONCLUSIONS
  VAS at birth did not reduce rotavirus morbidity. The effect of VAS on nonrotavirus diarrhea may differ by sex, being more beneficial in boys. Clinical trials registration. NCT00168597 .
authors.affiliation: Bandim Health Project, INDEPTH Network, Guinea-Bissau. Birgitte@Diness.dk
authors.forename: Birgitte Rode
authors.initials: BR
authors.lastname: Diness
authors.forename: Dorthe
authors.initials: D
authors.lastname: Christoffersen
authors.forename: Ulla Britt
authors.initials: UB
authors.lastname: Pedersen
authors.forename: Amabelia
authors.initials: A
authors.lastname: Rodrigues
authors.forename: Thea Kølsen
authors.initials: TK
authors.lastname: Fischer
authors.forename: Andreas
authors.initials: A
authors.lastname: Andersen
authors.forename: Hilton
authors.initials: H
authors.lastname: Whittle
authors.forename: Maria
authors.initials: M
authors.lastname: Yazdanbakhsh
authors.forename: Peter
authors.initials: P
authors.lastname: Aaby
authors.forename: Christine Stabell
authors.initials: CS
authors.lastname: Benn
mesh_terms: D000367:Age Factors; D001500:BCG Vaccine / Q000008:administration & dosage*; D003967:Diarrhea / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D004196:Disease Outbreaks / Q000517:prevention & control; D005260:Female; D006169:Guinea-Bissau / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D012737:Sex Factors; D014801:Vitamin A / Q000008:administration & dosage / Q000627:therapeutic use*; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D001500:BCG Vaccine; D014815:Vitamins; D014801:Vitamin A