NCT00666367

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2008

Typical duration for phase_4 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 24, 2010

Status Verified

October 1, 2009

Enrollment Period

2.4 years

First QC Date

April 23, 2008

Last Update Submit

December 23, 2010

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • median time to next exacerbation.

    1 year

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

D-cureDRUG

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

Also known as: license number: D-cure: 465S37F11
1
PlaceboDRUG

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

Also known as: Product number: Arachidis oleum raffinatum: *FA072892*
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Tiffeneau index \>70% or FEV1 \>80%
  • Hypercalcemia
  • Sarcoidosis
  • Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
  • Active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Katholieke Universiteit Leuven

Leuven, Flanders, 3000, Belgium

Location

University hospital Leuven

Leuven, Flanders, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 35236342DERIVED

  • 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.

    PMID: 22250141DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wim Janssens, Prof.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 24, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

December 24, 2010

Record last verified: 2009-10

Locations

BE(2)