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

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

• Registration Number: EUCTR2009-010084-16-GB
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Study Completion: 2013-07-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified