title: High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial.
abstract: BACKGROUND
  Low serum 25-hydroxyvitamin D (25-[OH]D) levels have been associated with lower FEV(1), impaired immunologic control, and increased airway inflammation. Because many patients with chronic obstructive pulmonary disease (COPD) have vitamin D deficiency, effects of vitamin D supplementation may extend beyond preventing osteoporosis.
  
  
  OBJECTIVE
  To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations.
  
  
  METHODS
  Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367)
  
  
  METHODS
  University Hospitals Leuven, Leuven, Belgium.
  
  
  METHODS
  182 patients with moderate to very severe COPD and a history of recent exacerbations.
  
  
  METHODS
  100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year.
  
  
  METHODS
  The primary outcome was time to first exacerbation. Secondary outcomes were exacerbation rate, time to first hospitalization, time to second exacerbation, FEV(1), quality of life, and death.
  
  
  RESULTS
  Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group (mean between-group difference, 30 ng/mL [95% CI, 27 to 33 ng/mL]; P < 0.001). The median time to first exacerbation did not significantly differ between the groups (hazard ratio, 1.1 [CI, 0.82 to 1.56]; P = 0.41), nor did exacerbation rates, FEV(1), hospitalization, quality of life, and death. However, a post hoc analysis in 30 participants with severe vitamin D deficiency (serum 25-[OH]D levels <10 ng/mL) at baseline showed a significant reduction in exacerbations in the vitamin D group (rate ratio, 0.57 [CI, 0.33 to 0.98]; P = 0.042).
  
  
  CONCLUSIONS
  This was a single-center study with a small sample size.
  
  
  CONCLUSIONS
  High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations. In participants with severe vitamin D deficiency at baseline, supplementation may reduce exacerbations.
  
  
  BACKGROUND
  Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM).
authors.affiliation: University Hospitals Leuven, Belgium.
authors.forename: An
authors.initials: A
authors.lastname: Lehouck
authors.forename: Chantal
authors.initials: C
authors.lastname: Mathieu
authors.forename: Claudia
authors.initials: C
authors.lastname: Carremans
authors.forename: Femke
authors.initials: F
authors.lastname: Baeke
authors.forename: Jan
authors.initials: J
authors.lastname: Verhaegen
authors.forename: Johan
authors.initials: J
authors.lastname: Van Eldere
authors.forename: Brigitte
authors.initials: B
authors.lastname: Decallonne
authors.forename: Roger
authors.initials: R
authors.lastname: Bouillon
authors.forename: Marc
authors.initials: M
authors.lastname: Decramer
authors.forename: Wim
authors.initials: W
authors.lastname: Janssens
mesh_terms: D000368:Aged; D023181:Antimicrobial Cationic Peptides / Q000097:blood; D002423:Cause of Death; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000517:prevention & control; D010587:Phagocytosis; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D011788:Quality of Life; D012008:Recurrence; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000097:blood; D054804:Cathelicidins
chemical_list: D023181:Antimicrobial Cationic Peptides; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D054804:Cathelicidins