Vitamin D as treatment for COPD

Phase 1

• Conditions: This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomised placebo-controlled study. For this purpose, 180 patients hospitalised with an exacerbation of COPD will be included and will be randomly assigned to a monthly oral dose of Vitamin D versus placebo.; MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD; MedDRA version: 9.1Level: LLTClassification code 10010953Term: COPD exacerbation

• Registration Number: EUCTR2007-004755-11-BE
• Lead Sponsor: niversity Hospital, Catholic University of Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-09
• Study Completion: 2010-07-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- Primary diagnosis of COPD exacerbation, regardless of the presence of component pneumonia, heart failure or co-morbidity
- Smoking history of at least ten pack years
- GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry
- informed consent obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Tiffeneau index >70% or FEV1 >80%
- Hypercalcemia
- Sarcoidosis
- Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
- Active cancer

Study & Design

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