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

High Dosis of Vitamin D as Treatment for COPD.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00666367
Enrollment
182
Registered
2008-04-24
Start date
2008-01-31
Completion date
2010-08-31
Last updated
2010-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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.

Interventions

DRUGD-cure

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

DRUGPlacebo

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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
median time to next exacerbation.1 year

Secondary

MeasureTime 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026