Vitamin D as treatment for COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004755-11-BE

Enrollment

180

Registered

2007-11-09

Start date

2007-11-29

Completion date

Unknown

Last updated

2021-05-03

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

Conditions

This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomised placebo-controlled study. For this purpose, 180 patients hospitalised with an exacerbation of COPD will be included and will be randomly assigned to a monthly oral dose of Vitamin D versus placebo. MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD MedDRA version: 9.1 Level: LLT Classification code 10010953 Term: COPD exacerbation

Interventions

Trade Name: D-Cure Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Primary diagnosis of COPD exacerbation, regardless of the presence of component pneumonia, heart failure or co-morbidity - Smoking history of at least ten pack years - GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry - informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Tiffeneau index >70% or FEV1 >80% - Hypercalcemia - Sarcoidosis - Newly discovered symptomatic osteoporosis (proven by DEXA and RX ) - Active cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the therapeutic effect of Vitamin D in the chronic maintenance treatment of COPD by means of a prospective randomised placebo-controlled double blind study of 180 patients with a follow-up of at least one year. Primary endpoint is the median time to next exacerbation. ;Secondary Objective: 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.;Primary end point(s): Median time to next exacerbation	—

Measure

Time frame

Main Objective: To define the therapeutic effect of Vitamin D in the chronic maintenance treatment of COPD by means of a prospective randomised placebo-controlled double blind study of 180 patients with a follow-up of at least one year. Primary endpoint is the median time to next exacerbation. ;Secondary Objective: 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.;Primary end point(s): Median time to next exacerbation

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026