Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease

The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to moderate/severe exacerbation of chronic obstructive pulmonary disease.

Principal Inclusion Criteria:

• Medical record diagnosis of COPD, emphysema or bronchitis
• Post-bronchodilator FEV1 / FVC < 70% or post-bronchodilator FEV1 / slow VC < 70%
• Post-bronchodilator FEV1 < 80% predicted
• Age ≥ 40 years on day of first dose of IMP
• Smoking history ≥ 15 pack-years
• If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
• Able to give written informed consent to participate

Exclusion Criteria:

• Current diagnosis of asthma
• Known clinically significant bronchiectasis
• Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years
• Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
• Taking dietary supplement or topical preparation containing vitamin D up to 2 months before first dose of IMP
• Treatment with any investigational medical product or device up to 4 months before first dose of IMP
• Breastfeeding, pregnant or planning a pregnancy
• Baseline corrected serum calcium > 2.65 mmol/L
• Baseline serum creatinine > 125 micromol/L