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. DESIGN: Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367) SETTING: University Hospitals Leuven, Leuven, Belgium. PATIENTS: 182 patients with moderate to very severe COPD and a history of recent exacerbations. INTERVENTION: 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year. MEASUREMENTS: 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 withsevere 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). LIMITATION: This was a single-center study with a small sample size. CONCLUSION: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. PRIMARY FUNDING SOURCE: Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM).
RCT Entities:
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. DESIGN: Randomized, single-center, double-blind, placebo-controlled trial. (ClinicalTrials.gov registration number: NCT00666367) SETTING: University Hospitals Leuven, Leuven, Belgium. PATIENTS: 182 patients with moderate to very severe COPD and a history of recent exacerbations. INTERVENTION: 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year. MEASUREMENTS: 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). LIMITATION: This was a single-center study with a small sample size. CONCLUSION: 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. PRIMARY FUNDING SOURCE: Applied Biomedical Research Program, Agency for Innovation by Science and Technology (IWT-TBM).
Authors: David E Leaf; Anas Raed; Michael W Donnino; Adit A Ginde; Sushrut S Waikar Journal: Am J Respir Crit Care Med Date: 2014-09-01 Impact factor: 21.405
Authors: E M Brouwer-Brolsma; H A Bischoff-Ferrari; R Bouillon; E J M Feskens; C J Gallagher; E Hypponen; D J Llewellyn; E Stoecklin; J Dierkes; A K Kies; F J Kok; C Lamberg-Allardt; U Moser; S Pilz; W H Saris; N M van Schoor; P Weber; R Witkamp; A Zittermann; L C P G M de Groot Journal: Osteoporos Int Date: 2012-12-11 Impact factor: 4.507
Authors: Christine Rake; Clare Gilham; Laurette Bukasa; Richard Ostler; Michelle Newton; James Peto Wild; Benoit Aigret; Michael Hill; Oliver Gillie; Irwin Nazareth; Peter Sasieni; Adrian Martineau; Julian Peto Journal: Health Technol Assess Date: 2020-02 Impact factor: 4.014