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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00666367
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:
KU Leuven

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: D-cure Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: High Dosis of Vitamin D as Treatment for COPD.
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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*


Outcome Measures
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Primary Outcome Measures :
  1. median time to next exacerbation. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666367


Locations
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Belgium
Katholieke Universiteit Leuven
Leuven, Flanders, Belgium, 3000
University hospital Leuven
Leuven, Flanders, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Wim Janssens, Prof. KU Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. W. Janssens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00666367    
Other Study ID Numbers: 2007-004755-11
S50722
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: October 2009
Keywords provided by KU Leuven:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes