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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-010084-16-GB |
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Date of registration:
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22/05/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients with Chronic Obstructive Pulmonary Disease - Trial of vitamin D supplementation in COPD
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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 - Trial of vitamin D supplementation in COPD |
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Date of first enrolment:
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24/07/2009 |
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Target sample size:
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240 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010084-16 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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 • Exacerbation of COPD requiring treatment with antibiotics and / or systemic corticosteroids within 12 months of screening visit • Contactable by telephone and able to attend face-to-face review at 2, 6 and 12 months post-enrolment • 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
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 • Any other condition that, in an investigator’s judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study • COPD requiring long-term oxygen therapy = 12 hours per day • Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone • Taking dietary supplement 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 • URTI or COPD exacerbation up to 28 days before first dose of IMP • Inability to use spirometer • Inability to complete symptom diary
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
MedDRA version: 14.1
Level: LLT
Classification code 10010952
Term: COPD
System Organ Class: 100000004855
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Intervention(s)
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Trade Name: Vigantol oil
Product Name: Vigantol oil
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: 1.Does vitamin D supplementation influence other respiratory symptoms in patients with COPD? 2.Does vitamin D supplementation influence health service use in patients with COPD? 3.Does vitamin D supplementation influence risk of adverse events in patients with COPD? 4.Does vitamin D supplementation influence medication use in patients with COPD? 5.Does vitamin D supplementation influence lung function in patients with COPD? 6.Does vitamin D supplementation influence muscle strength in patients with COPD? 7.Does vitamin D supplementation influence quality of life in patients with COPD? 8.Does vitamin D supplementation influence economic outcomes including illness-related costs and days of absence from work in patients with COPD?
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Main Objective: Does Vitamin D supplementation influence time to first moderate / severe exacerbation and time to first upper respiratory tract infection in patients with COPD?
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Primary end point(s): The co- primary outcome measures for the study are: 1. Time from randomisation to first moderate or severe COPD exacerbation. 2. Time from randomisation to first upper respiratory tract infection.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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