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

NCT ID: NCT00666367

Last Updated: 2010-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

D-cure

Intervention Type: DRUG

4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.

Interventions

D-cure

4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.

Intervention Type: DRUG

Placebo

4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.

Intervention Type: DRUG

Other Intervention Names

license number: D-cure: 465S37F11; Product number: Arachidis oleum raffinatum: *FA072892*

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Katholieke Universiteit Leuven

Principal Investigators

Wim Janssens, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Katholieke Universiteit Leuven

Leuven, Flanders, Belgium

University hospital Leuven

Leuven, Flanders, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 35236342 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22250141 (View on PubMed)

Other Identifiers

S50722

Identifier Type: -

Identifier Source: secondary_id

2007-004755-11

Identifier Type: -

Identifier Source: org_study_id