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
- Conditions
- AsthmaMedDRA version: 14.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
- Registration Number
- EUCTR2009-010083-42-GB
- Lead Sponsor
- Barts Health NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
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: • 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method