Skip to main content
OpenTrials
Completed

NCT Number: NCT00666367

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Katholieke Universiteit Leuven, Leuven, Flanders, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-cure

Drug

4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.

Other names: license number: D-cure: 465S37F11

Placebo

Drug

4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.

Other names: Product number: Arachidis oleum raffinatum: *FA072892*

Primary outcomes

  1. median time to next exacerbation.

    Time frame: 1 year

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

High Dosis of Vitamin D as Treatment for COPD.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 24, 2008
Registry last updated
Dec 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.