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

Sponsor:	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, 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

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

Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

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 ]

Enrollment:	182
Study Start Date:	January 2008
Study Completion Date:	August 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: D-cure 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.	Drug: Placebo 4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser. Other Name: Product number: Arachidis oleum raffinatum: FA072892

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.

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

Locations

Belgium
Katholieke Universiteit Leuven
Leuven, Flanders, Belgium, 3000
University hospital Leuven
Leuven, Flanders, Belgium, 3000

Sponsors and Collaborators

Katholieke Universiteit Leuven

Investigators

Principal Investigator:

Wim Janssens, Prof.

Katholieke Universiteit Leuven

More Information

No publications provided

Responsible Party:	Prof. Dr. W. Janssens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00666367 History of Changes
Other Study ID Numbers:	2007-004755-11, S50722
Study First Received:	April 23, 2008
Last Updated:	December 23, 2010
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Vitamin D
Ergocalciferols

Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012