Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
High Dosis of Vitamin D as Treatment for COPD.
This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study
Status | Completed |
Enrollment | 182 |
Est. completion date | August 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Primary diagnosis of COPD exacerbation - Smoking history of at least ten pack years - GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry - Informed consent Exclusion Criteria: - Tiffeneau index >70% or FEV1 >80% - Hypercalcemia - Sarcoidosis - Newly discovered symptomatic osteoporosis (proven by DEXA and RX ) - Active cancer |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Katholieke Universiteit Leuven | Leuven | Flanders |
Belgium | University hospital Leuven | Leuven | Flanders |
Lead Sponsor | Collaborator |
---|---|
Katholieke Universiteit Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | median time to next exacerbation. | 1 year | No | |
Secondary | Total number of exacerbations per group, number of exacerbations per patient per year, percentage of patients with one or more exacerbations per year, days of antibiotics and oral steroids, quality of life, FEV1, muscle force and survival. | 1 year | No |
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