Status:
COMPLETED
Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
National Health Service, United Kingdom
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
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 diseas...
Eligibility Criteria
Inclusion
- Principal
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00977873
Start Date
September 1 2009
End Date
July 1 2013
Last Update
February 4 2014
Active Locations (4)
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1
Lower Clapton Health Centre
London, United Kingdom, E5 0PD
2
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
3
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1
4
Barts and The London NHS Trust
London, United Kingdom