Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (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
Chronic Obstructive Pulmonary Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||High Dosis of Vitamin D as Treatment for COPD.|
- median time to next exacerbation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Vitamin D (D-cure) will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.
Other Name: license number: D-cure: 465S37F11
Placebo Comparator: 2
Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.
4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.
Other Name: Product number: Arachidis oleum raffinatum: *FA072892*
Principal objective: To define the therapeutic effect of Vitamin D in the chronic maintenance treatment of COPD by means of a prospective randomized placebo-controlled double blind study of 182 patients with a follow-up of at least one year. Primary endpoint is the median time to next exacerbation. Secondary endpoints are 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.
Other objectives: First, to investigate the role of local and systemic levels of 25-OHD and 1,25-(OH)2D on the intensity and prevalence of bacterial colonisation, inflammatory markers, proteases and markers of oxidative stress in induced sputa and exhaled air. Second, to explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the VDR-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666367
|Katholieke Universiteit Leuven|
|Leuven, Flanders, Belgium, 3000|
|University hospital Leuven|
|Leuven, Flanders, Belgium, 3000|
|Principal Investigator:||Wim Janssens, Prof.||Katholieke Universiteit Leuven|