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Main
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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: |
EUCTR2009-010083-42-GB |
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Date of registration:
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19/10/2010 |
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Prospective Registration:
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No |
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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 ADULT AND ADOLESCENT PATIENTS WITH ASTHMA - Trial of vitamin D supplementation in asthma
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Scientific title:
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RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF VITAMIN D SUPPLEMENTATION IN ADULT AND ADOLESCENT PATIENTS WITH ASTHMA - Trial of vitamin D supplementation in asthma |
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Date of first enrolment:
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29/06/2009 |
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Target sample size:
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250 |
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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:2009-010083-42 |
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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: no
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:
Inclusion Criteria: • Medical record diagnosis of asthma, treated at BTS step 2 or above for at least 28 days before first dose of IMP • One or more of the following, documented within the last 3 years: o = 12% increase in FEV1 after inhalation of 400 micrograms of salbutamol o = 20% diurnal variability in peak expiratory flow o Methacholine PC20 (concentration of methacholine causing a 20% fall in FEV1) < 8 g/L • Age = 12 years and = 80 years on day of first dose of IMP • 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 in the study if aged = 16 years; if aged < 16 years, able to give assent, with a parent or guardian able to give written informed consent for the subject to participate in the study
Are the trial subjects under 18? yes
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:
Exclusion Criteria: • Diagnosis of COPD as defined by the GOLD guidelines • 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 • 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 • Smoking history >15 pack-years • Severe asthma exacerbation or URTI up to 28 days before first dose of IMP • Inability to use spirometer or PEFR meter • Inability to complete diary of symptoms and PEFR
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma
MedDRA version: 14.1
Level: LLT
Classification code 10003555
Term: Asthma bronchial
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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Main Objective: Does vitamin D supplementation influence time to first severe exacerbation and time to first upper respiratory tract infection in patients with asthma?
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Secondary Objective: 1. Does vitamin D supplementation influence other respiratory symptoms in patients with asthma? 2. Does vitamin D supplementation influence health service use in patients with asthma? 3. Does vitamin D supplementation influence risk of adverse events in patients with asthma? 4. Does vitamin D supplementation influence medication use in patients with asthma? 5. Does vitamin D supplementation influence lung function in patients with asthma? 6. Does vitamin D supplementation influence quality of life in patients with asthma? 7. Does vitamin D supplementation influence economic outcomes including illness-related costs and days of absence from work in patients with asthma?
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Primary end point(s): The co-primary outcome measures for the study are: 1. Time from randomisation to first severe asthma 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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