Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
NCT ID: NCT00977873
Last Updated: 2014-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
240 participants
INTERVENTIONAL
2009-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vigantol oil
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Miglyol oil
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
Interventions
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Cholecalciferol
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil
Miglyol oil will be administered in 2-monthly bolus doses over a period of one year
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Adrian R Martineau, MRCP
Role: STUDY_DIRECTOR
Queen Mary University of London
Locations
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Lower Clapton Health Centre
London, , United Kingdom
Homerton University Hospital NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Barts and The London NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2009-010084-16
Identifier Type: -
Identifier Source: org_study_id
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