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

• ClinicalTrials.gov Identifier: NCT00666367
• Recruitment Status: Completed
• First Posted: April 24, 2008
• Last Update Posted: December 24, 2010
• Sponsor: KU Leuven
• Information provided by: KU Leuven

Tracking Information

• First Submitted Date: April 23, 2008
• First Posted Date: April 24, 2008
• Last Update Posted Date: December 24, 2010
• Study Start Date: January 2008
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 23, 2008): median time to next exacerbation. [ Time Frame: 1 year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease

Intervention

• 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

• 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 *

• Serre J, Tanjeko AT, Mathyssen C, Heigl T, Sacreas A, Cook DP, Verbeken E, Maes K, Verhaegen J, Pilette C, Vanoirbeek J, Gysemans C, Mathieu C, Vanaudenaerde B, Janssens W, Gayan-Ramirez G. Effects of repeated infections with non-typeable Haemophilus influenzae on lung in vitamin D deficient and smoking mice. Respir Res. 2022 Mar 2;23(1):40. doi: 10.1186/s12931-022-01962-6.
• Lehouck A, Mathieu C, Carremans C, Baeke F, Verhaegen J, Van Eldere J, Decallonne B, Bouillon R, Decramer M, Janssens W. High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2012 Jan 17;156(2):105-14. doi: 10.7326/0003-4819-156-2-201201170-00004.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 23, 2010): 182
• Original Estimated Enrollment (submitted: April 23, 2008): 120
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT00666367
• Other Study ID Numbers: 2007-004755-11; S50722
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. W. Janssens, Katholieke Universiteit Leuven
• Original Responsible Party: Same as current
• Current Study Sponsor: KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wim Janssens, Prof.; KU Leuven

• PRS Account: KU Leuven
• Verification Date: October 2009