Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Miglyol oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vigantol oil<br>Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year | Dietary Supplement: Cholecalciferol<br>* Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year<br>|
| Placebo Comparator: Miglyol oil<br>Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year | Dietary Supplement: Miglyol oil<br>* Miglyol oil will be administered in 2-monthly bolus doses over a period of one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first upper respiratory tract infection |  | One year | 
| Time to first moderate / severe COPD exacerbation |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease |  | One year | 
| Proportion of participants experiencing hypercalcaemia |  | One year |