Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: D-cure; Drug: Placebo

• Registration Number: NCT00666367
• Lead Sponsor: KU Leuven

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Status Verified: 2009-10
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Last Update Submitted: 2010-12-23
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	D-cure	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.
2	Placebo	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.

Primary Outcome Measures

Name	Time	Method
median time to next exacerbation.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Flanders, Belgium

University hospital Leuven; 🇧🇪 Leuven, Flanders, Belgium