title: Effect on the incidence of pneumonia of vitamin D supplementation by quarterly bolus dose to infants in Kabul: a randomised controlled superiority trial.
abstract: BACKGROUND
  Vitamin D has a role in regulating immune function, and its deficiency is a suggested risk factor for childhood pneumonia. Our aim was to assess whether oral supplementation of vitamin D(3) (cholecalciferol) will reduce the incidence and severity of pneumonia in a high-risk infant population.
  
  
  METHODS
  We did a randomised placebo-controlled trial to compare oral 100,000 IU (2·5 mg) vitamin D(3) with placebo given to children aged 1-11 months in Kabul, Afghanistan. Randomisation was by use of a computer-generated list. Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months. Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically. Our primary outcome was the first or only episode of radiologically confirmed pneumonia. Our analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00548379.
  
  
  RESULTS
  1524 children were assigned to receive vitamin D(3) and 1522 placebo. There was no significant difference between the incidence of first or only pneumonia between the vitamin D (0·145 per child per year, 95% CI 0·129-0·164) and the placebo group (0.137, 0·121-0·155); the incidence rate ratio was 1·06 (95% CI 0·89-1·27). From 652 children during five separate periods of testing serum calcifediol, only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group--a toxic level.
  
  
  CONCLUSIONS
  Quarterly bolus doses of oral vitamin D(3) supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting.
  
  
  BACKGROUND
  Wellcome Trust and British Council.
authors.affiliation: School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. s.manasekiholland@bham.ac.uk
authors.forename: Semira
authors.initials: S
authors.lastname: Manaseki-Holland
authors.forename: Zabihullah
authors.initials: Z
authors.lastname: Maroof
authors.forename: Jane
authors.initials: J
authors.lastname: Bruce
authors.forename: M Zulf
authors.initials: MZ
authors.lastname: Mughal
authors.forename: Mohammad Isaq
authors.initials: MI
authors.lastname: Masher
authors.forename: Zulfiqar A
authors.initials: ZA
authors.lastname: Bhutta
authors.forename: Gijs
authors.initials: G
authors.lastname: Walraven
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
mesh_terms: D000346:Afghanistan / Q000453:epidemiology; D016001:Confidence Intervals; D003906:Developing Countries; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011014:Pneumonia / Q000188:drug therapy* / Q000453:epidemiology* / Q000517:prevention & control; D020551:Pulse Therapy, Drug; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage*
chemical_list: D014807:Vitamin D