Randomised, multicentre, double-blind, placebo-controlled trial of vitamin D supplementation in patients with chronic obstructive pulmonary disease (COPD)

Barts and The London School of Medicine and Dentistry0 个研究点目标入组 240 人开始时间: 2010年5月12日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Medical record diagnosis of COPD, emphysema or bronchitis
•2. Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70% or post-bronchodilator FEV1/slow vital capacity (VC) less than 70%
•3. Post-bronchodilator FEV1 less than 80% predicted
•4. Age 40 years on day of first dose of IMP, either sex
•5. Smoking history 15 pack-years
•6. Exacerbation of COPD requiring treatment with antibiotics and/or systemic corticosteroids within 12 months of screening visit
•7. Contactable by telephone and able to attend face-to-face review at 2, 6 and 12 months post-enrolment
•8. 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
•9. Able to give written informed consent to participate

•1. Current diagnosis of asthma
•2. Known clinically significant bronchiectasis
•3. 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
•4. Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
•5. COPD requiring long-term oxygen therapy 12 hours per day
•6. Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
•7. Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
•8. Treatment with any investigational medical product or device up to 4 months before first dose of IMP
•9. Breastfeeding, pregnant or planning a pregnancy
•10. Baseline corrected serum calcium greater than 2.65 mmol/L
•11. Baseline serum creatinine greater than 125 micromol/L
•12. Upper respiratory tract infection (URTI) or COPD exacerbation up to 28 days before first dose of IMP
•13. Inability to use spirometer
•14. Inability to complete symptom diary

发起方

Barts and The London School of Medicine and Dentistry