High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial
An Lehouck, Chantal Mathieu, Claudia Carremans, Femke Baeke, Jan Verhaegen, Johan Van Eldere, Brigitte Decallonne, Roger Bouillon, Marc Decramer, Wim Janssens, An Lehouck, Chantal Mathieu, Claudia Carremans, Femke Baeke, Jan Verhaegen, Johan Van Eldere, Brigitte Decallonne, Roger Bouillon, Marc Decramer, Wim Janssens
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.
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).
Source: PubMed