Chronic Obstructive Pulmonary DiseasePhase 4NCT00666367
Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing D-cure in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- D-cure
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Tiffeneau index >70% or FEV1 >80%
- Hypercalcemia
- Sarcoidosis
- Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
- Active cancer
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Katholieke Universiteit Leuven
Leuven, Flanders, 3000
University hospital Leuven
Leuven, Flanders, 3000
About this study
Official title: 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
Read the 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
- Being tested
- D-cure, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cureDrug
Also called license number: D-cure: 465S37F11
4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.
PlaceboDrug
Also called Product number: Arachidis oleum raffinatum: *FA072892*
4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
median time to next exacerbation.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Wim Janssens, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666367
- Sponsor's protocol ID
- 2007-004755-11
- Other IDs
- S50722
- Status last verified
- Oct 2009
- First submitted
- 23 Apr 2008
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35236342Lehouck 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.
PubMed 22250141
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dosis of Vitamin D as Treatment for COPD.
- ClinicalTrials.gov ID
- NCT00666367
- Acronym / sponsor ID
- 2007-004755-11
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: D-cureVitamin 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. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Tiffeneau index >70% or FEV1 >80%
- Hypercalcemia
- Sarcoidosis
- Newly discovered symptomatic osteoporosis (proven by DEXA and RX )
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cureAlso: license number: D-cure: 465S37F114 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser. | Drug | 1 |
| PlaceboAlso: Product number: Arachidis oleum raffinatum: *FA072892*4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser. | Drug | 2 |
Primary outcome
median time to next exacerbation.
Time frame: 1 year
1 secondary outcome
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.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Derived from this study: PubMed 35236342Serre 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.
- Derived from this study: PubMed 22250141Lehouck 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.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Janssens, Prof. principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D-cure in people with Chronic Obstructive Pulmonary Disease, run by KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median time to next exacerbation. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.