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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT00977873 |
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Date of registration:
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14/09/2009 |
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Primary sponsor: |
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Public title:
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Trial of Vitamin D Supplementation in Chronic Obstructive Pulmonary Disease
ViDiCO |
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Scientific title:
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Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients With Chronic Obstructive Pulmonary Disease |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00977873 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Adrian R Martineau, MRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Queen Mary University of London |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Dietary Supplement: Cholecalciferol
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Dietary Supplement: Miglyol oil
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Primary Outcome(s)
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Time to first moderate / severe COPD exacerbation
[Time Frame: One year]
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Time to first upper respiratory tract infection
[Time Frame: One year]
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Secondary Outcome(s)
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Proportion of participants experiencing hypercalcaemia
[Time Frame: One year]
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Time to unscheduled health service use for upper respiratory tract infection or moderate / severe exacerbation of chronic obstructive pulmonary disease
[Time Frame: One year]
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Secondary ID(s)
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2009-010084-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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