Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
ViDiCO
Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
240
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Sep 2009
Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 14, 2009
CompletedFirst Posted
Study publicly available on registry
September 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 4, 2014
February 1, 2014
3.8 years
September 14, 2009
February 3, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Time to first upper respiratory tract infection
One year
Time to first moderate / severe COPD exacerbation
One year
Secondary Outcomes (2)
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
Study Arms (2)
Vigantol oil
ACTIVE COMPARATORVigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oil
PLACEBO COMPARATORMiglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Interventions
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lower Clapton Health Centre
London, E5 0PD, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, E9 6SR, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1, United Kingdom
Barts and The London NHS Trust
London, United Kingdom
Related Publications (1)
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.
PMID: 25476069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adrian R Martineau, MRCP
Queen Mary University of London
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2009
First Posted
September 16, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-02