Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00666367

Purpose

This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, 120 patients hospitalized with an exacerbation of COPD will be included and will be randomly assigned to a monthly oral dose of Vitamin D versus placebo.

We hypothesize that improved vitamin D status will reduce or prevent bacterial colonisation, decrease inflammation and improve COPD outcomes.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: D-cure Drug: Placebo	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Vitamin D Ergocalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	High Dosis of Vitamin D as Treatment for COPD.

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

median time to next exacerbation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Drug: D-cure 4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.
2: Placebo Comparator 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.	Drug: Placebo 4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.

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 120 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666367

Contacts

Contact: Wim Janssens, Prof.	+032 (16) 34 68 00	wim.janssens@uz.kuleuven.be
Contact: Claudia Carremans	+032 (16) 34 31 30	claudia.carremans@uz.kuleuven.be

Locations

Belgium, Flanders
Katholieke Universiteit Leuven	Recruiting
Leuven, Flanders, Belgium, 3000
Contact: Wim Janssens, Prof 032 (16) 34 68 00 wim.janssens@uz.kuleuven.be
Contact: Claudia Carremans 032 (16) 34 31 30 claudia.carremans@uz.kuleuven.be
University hospital Leuven	Recruiting
Leuven, Flanders, Belgium, 3000
Principal Investigator: Wim Janssens, MD, PhD
Sub-Investigator: Marc Decramer, MD Phd
Sub-Investigator: Roger Bouillon, MD Phd
Sub-Investigator: Chantal Mathieu, MD Phd
Sub-Investigator: Johan Van Eldere, MD Phd
Sub-Investigator: Jan Verhaegen, MD Phd

Sponsors and Collaborators

Katholieke Universiteit Leuven

Investigators

Principal Investigator:

Wim Janssens, Prof.

Katholieke Universiteit Leuven

More Information

Responsible Party:	Katholieke Universiteit Leuven ( Prof. Dr. W. Janssens )
Study ID Numbers:	2007-004755-11, S50722
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666367
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:

COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Vitamin D
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Ergocalciferols
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009