Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
DIETARY_SUPPLEMENTMiglyol oil
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
Sponsors
National Health Service, United Kingdom
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first upper respiratory tract infection | One year |
| Time to first moderate / severe COPD exacerbation | One year |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed