title: Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial.
abstract: Trials in school-aged children suggest vitamin D supplementation reduces asthma exacerbations. Primary aim: to examine whether vitamin D3 (100,000 IU) rapidly raises serum 25-hydroxyvitamin D (25OHD) ≥75 nmol/L in asthmatic preschoolers.
  
  
  
  In a double-blind, randomised, placebo-controlled trial, preschool-aged children with asthma received 100,000 IU vitamin D3 (intervention) or placebo (control), followed by 400 IU vitamin D3 daily for 6 months. Serum 25OHD was measured at baseline, 10 days, 3 and 6 months. Outcomes included the group difference in 25OHD change from baseline at 3 months (Δ25OHD); the proportion of children with 25OHD ≥75 nmol/L at 3 months; the pattern in serum vitamin D over 6 months; the proportion of children with hypercalciuria at any time point (safety); and group rates for oral corticosteroids. Continuous outcomes were analysed using generalised linear mixed models and group rate ratios of events per child were assessed using a Poisson distribution model.
  
  
  
  Twenty-two children were randomised (intervention:11; control:11) during winter. At 3 months, the group difference in Δ25OHD (7.2 nmol/L; 95 % CI: -13.7, 28.1) was not significant; yet, 100 % versus 54.5 % (intervention versus control) had serum 25OHD ≥75 nmol/L. There was a significant group difference in Δ25OHD at 10 days (110.3 nmol/L; 95 % CI: 64.0, 156.6). One child in each group had transient hypercalciuria at 10 days. Group oral corticosteroids rates were 0.82 and 1.18/child, intervention versus control (rate ratio = 0.68; 95 % CI: 0.30, 1.62; non-significant).
  
  
  
  Following 100,000 IU vitamin D3, all children reached serum 25OHD ≥75 nmol/L, compared with half who received placebo. Daily supplementation, sun exposure and insufficient power may explain the absence of a significant 3-month group difference in Δ25OHD. No clinically important alterations in bone metabolism biomarkers occurred. Group oral corticosteroid rates will inform sample size calculations for the larger trial. ( NCT01999907 , 25 November 2013).
authors.affiliation: Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada. megan.jensen@newcastle.edu.au.
authors.forename: Megan E
authors.initials: ME
authors.lastname: Jensen
authors.affiliation: Department of Nutrition, University of Montreal, Montreal, QC, Canada.
authors.forename: Genevieve
authors.initials: G
authors.lastname: Mailhot
authors.affiliation: Department of Pediatrics, University of Montreal, Montreal, QC, Canada.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Alos
authors.affiliation: Department of Pediatrics, University of Montreal, Montreal, QC, Canada.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Rousseau
authors.affiliation: Department of Physiology and Medicine, McGill University, Montreal, QC, Canada.
authors.forename: John H
authors.initials: JH
authors.lastname: White
authors.affiliation: Euro-Pharm International Canada, Montreal, QC, Canada.
authors.forename: Ali
authors.initials: A
authors.lastname: Khamessan
authors.affiliation: Departments of Pediatrics and of Social and Preventive Medicine and Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Université de Montréal, Montreal, QC, Canada.
authors.forename: Francine M
authors.initials: FM
authors.lastname: Ducharme
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000367:Age Factors; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage; D001249:Asthma / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D015415:Biomarkers / Q000097:blood; D002675:Child, Preschool; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010865:Pilot Projects; D011792:Quebec; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D015415:Biomarkers; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D
keywords: Asthma; Child; Diet; Feasibility study; Paediatric; Randomised controlled trial; Vitamin D