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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

Tracking Information
First Submitted Date  ICMJE April 23, 2008
First Posted Date  ICMJE April 24, 2008
Last Update Posted Date December 24, 2010
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
median time to next exacerbation. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE High Dosis of Vitamin D as Treatment for COPD.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: D-cure
    4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.
    Other Name: license number: D-cure: 465S37F11
  • Drug: Placebo
    4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.
    Other Name: Product number: Arachidis oleum raffinatum: *FA072892*
Study Arms  ICMJE
  • 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.
    Intervention: Drug: D-cure
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2010)
182
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2008)
120
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666367
Other Study ID Numbers  ICMJE 2007-004755-11
S50722
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. W. Janssens, Katholieke Universiteit Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wim Janssens, Prof. KU Leuven
PRS Account KU Leuven
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP