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

INTERVENTION: Trade Name: Vigantol oil Product Name: Vigantol oil Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use CONDITION: Chronic Obstructive Pulmonary Disease ; MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 PRIMARY OUTCOME: Main Objective: Does Vitamin D supplementation influence time to first moderate / severe exacerbation and time to first upper respiratory tract infection in patients with COPD? Primary end point(s): The co‐ primary outcome measures for the study are: 1. Time from randomisation to first moderate or severe COPD exacerbation. 2. Time from randomisation to first upper respiratory tract infection. Secondary Objective: 1.Does vitamin D supplementation influence other respiratory symptoms in patients with COPD? 2.Does vitamin D supplementation influence health service use in patients with COPD? 3.Does vitamin D supplementation influence risk of adverse events in patients with COPD? 4.Does vitamin D supplementation influence medication use in patients with COPD? 5.Does vitamin D supplementation influence lung function in patients with COPD? 6.Does vitamin D supplementation influence muscle strength in patients with COPD? 7.Does vitamin D supplementation influence quality of life in patients with COPD? 8.Does vitamin D supplementation influence economic outcomes including illness‐related costs and days of absence from work in patients with COPD? 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 • Exacerbation of COPD requiring treatment with antibiotics and / or systemic corticosteroids within 12 months of screening visit • Contactable by telephone and able to attend face‐to‐face review at 2, 6 and 12 months post‐enrolment • 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Numb