Randomised, multi-centre, double-blind, placebo-controlled prevention trial of vitamin D supplementation in adult and adolescent patients with asthma

Barts and The London NHS Trust (UK)0 个研究点目标入组 250 人开始时间: 2010年5月19日最近更新: 2022年11月28日

适应症

试验速览

•1. Medical record diagnosis of asthma, treated at British Thoracic Society (BTS) step 2 or above for at least 28 days before first dose of investigational medical product (IMP)
•2. One or more of the following, documented within the last 3 years:
•2.1. 12% increase in forced expiratory volume in one second (FEV1) after inhalation of 400 micrograms of salbutamol
•2.2. 20% diurnal variability in peak expiratory flow
•2.3. Methacholine PC20 (concentration of methacholine causing a 20% fall in FEV1) less than 8 g/L
•3. Age 12 years and 80 years on day of first dose of IMP, either sex
•4. Contactable by telephone and able to attend face-to-face review at 2, 6 and 12 months post-enrolment
•5. 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
•6. Able to give written informed consent to participate in the study if aged 16 years; if aged less than 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

•1. Diagnosis of COPD as defined by the GOLD guidelines
•2. 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
•3. Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
•4. Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
•5. Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
•6. Treatment with any investigational medical product or device up to 4 months before first dose of IMP
•7. Breastfeeding, pregnant or planning a pregnancy
•8. Baseline corrected serum calcium greater than 2.65 mmol/L
•9. Baseline serum creatinine greater than 125 micromol/L
•10. Smoking history greater than 15 pack-years
•11. Severe asthma exacerbation or URTI up to 28 days before first dose of IMP
•12. Inability to use spirometer or peak expiratory flow rate (PEFR) meter
•13. Inability to complete diary of symptoms and PEFR

发起方

Barts and The London NHS Trust (UK)