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

High Dosis of Vitamin D as Treatment for COPD.

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: D-cure; Drug: Placebo

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
• Enrollment (Actual): 182
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Leuven, Flanders, Belgium, 3000
      • Katholieke Universiteit Leuven
    • Leuven, Flanders, Belgium, 3000
      • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Product number: Arachidis oleum raffinatum: *FA072892*

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
median time to next exacerbation.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Wim Janssens, Prof., KU Leuven

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 24, 2008

Study Record Updates

• Last Update Posted (Estimate): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 23, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2007-004755-11; S50722