Clinical trial NCT00977873: Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
Official title: Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2009-09-16
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Time to first upper respiratory tract infection
timeFrame: One year
measure: Time to first moderate / severe COPD exacerbation
timeFrame: One year
Secondary outcomes:
measure: Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease
timeFrame: One year
measure: Proportion of participants experiencing hypercalcaemia
timeFrame: One year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lower Clapton Health Centre
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
Study officials:
affiliation: Queen Mary University of London
name: Adrian R Martineau, MRCP
role: STUDY_DIRECTOR
References:
citation: Martineau AR, James WY, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Islam K, McLaughlin D, Bhowmik A, Timms PM, Rajakulasingam RK, Rowe M, Venton TR, Choudhury AB, Simcock DE, Wilks M, Degun A, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2015 Feb;3(2):120-130. doi: 10.1016/S2213-2600(14)70255-3. Epub 2014 Dec 2.