Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00666367|
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : December 24, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: D-cure Drug: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.
Other Name: Product number: Arachidis oleum raffinatum: *FA072892*
- median time to next exacerbation. [ Time Frame: 1 year ]
- 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 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Tiffeneau index >70% or FEV1 >80%
- Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
- Active cancer
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
|Katholieke Universiteit Leuven|
|Leuven, Flanders, Belgium, 3000|
|University hospital Leuven|
|Leuven, Flanders, Belgium, 3000|
|Principal Investigator:||Wim Janssens, Prof.||KU Leuven|
|Responsible Party:||Prof. Dr. W. Janssens, Katholieke Universiteit Leuven|
|Other Study ID Numbers:||
|First Posted:||April 24, 2008 Key Record Dates|
|Last Update Posted:||December 24, 2010|
|Last Verified:||October 2009|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases