Chronic Obstructive Lung DiseasePhase 4NCT01416701
Vitamin D and Chronic Obstructive Lung Disease
A Phase 4 study testing Vitamin D (D3, cholecalciferol) in people with Chronic Obstructive Lung Disease, run by Jorgen Vestbo at 2 sites in Denmark.
Trial summary
The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- Vitamin D (D3, cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2011to Dec 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 50 % of predicted
- Breathlessness relative to MRC dyspnoea grade 3 or more
Who cannot join
- Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
- Patients with hyper- or hypocalcemia at inclusion
- Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
- Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
- Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
- Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital, Department of Respiratory Medicine
Hvidovre, 2650
Medical Unit, Hvidovre University Hospital
Hvidovre, 2650
About this study
Official title: Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance
The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.
- Conditions
- Chronic Obstructive Lung Disease
- Being tested
- Vitamin D (D3, cholecalciferol), Placebo (cellulose)
- Keywords
- COPD, Vitamin D, Pulmonary rehabilitation
- 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.
Vitamin D (D3, cholecalciferol)Dietary supplement
Also called Bio Vinci Mega D-vitamin
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
Placebo (cellulose)Dietary supplement
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (D3, cholecalciferol) | Active comparator | Not described Receives: Dietary Supplement: Vitamin D (D3, cholecalciferol) |
| Placebo (cellulose) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal from rehabilitation.
Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
Measured: 24 weeks
Improvement in walking distance
Change in walking distance from week 0 to week 24. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test(ISWT) and Endurance Shuttle Walk Test (ESWT)).
Measured: 24 weeks
Secondary outcomes (10)
Change in vitamin D status.
se-25-OHD se-PTH
Measured: 52 weeks
Change in calcium metabolic status.
se-calcium se-phosphate se-magnesium
Measured: 52 weeks
Change in quality of life.
COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ).
Measured: 52 weeks
Change in status of bone metabolism.
DXA (Dual energy X-ray Absorptiometry) scans
Measured: 52 weeks
Change in walking distance.
Change in walking distance from week 0 to week 11 and week 52. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test (ISWT) and Endurance Shuttle Walk Test (ESWT)).
Measured: 52 weeks
Change in fat mass and fat free mass.
Whole body DXA scans.
Measured: 52 weeks
Change in physical activity.
Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband).
Measured: 24 weeks
COPD exacerbations.
Measured: 52 weeks
All cause hospital admissions.
Measured: 52 weeks
All cause mortality.
Measured: 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: It was not possible to enroll the planned amount of subjects. Many patients with chronic obstructive pulmonary disease already took large doses of vitamin D.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorgen Vestbo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jorgen Vestbo, Hvidovre University Hospital
- Investigators
- Jørgen Vestbo, DMSc, Principal investigator, Hvidovre Universityl Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416701
- Sponsor's protocol ID
- DvitKOL01022011
- Status last verified
- Apr 2013
- First submitted
- 12 Aug 2011
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and COPD. A Randomised, Double-blind, Placebo-controlled Trial of the Effect of Vitamin D on Withdrawal From Pulmonary Rehabilitation and Exercise Endurance
- ClinicalTrials.gov ID
- NCT01416701
- Acronym / sponsor ID
- DvitKOL01022011
- Conditions
- Chronic Obstructive Lung Disease
- Keywords
- COPD, Vitamin D, Pulmonary rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was not possible to enroll the planned amount of subjects. Many patients with chronic obstructive pulmonary disease already took large doses of vitamin D.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jorgen VestboUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Aug 2011 (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.
The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.
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 |
|---|---|---|
| Vitamin D (D3, cholecalciferol) | Active comparator | Dietary Supplement: Vitamin D (D3, cholecalciferol) |
| Placebo (cellulose) | Placebo comparator | Dietary Supplement: Placebo (cellulose) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 50 years
- Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 50 % of predicted
- Breathlessness relative to MRC dyspnoea grade 3 or more
Key exclusion criteria (7 listed)
- Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
- Patients with hyper- or hypocalcemia at inclusion
- Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
- Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
- Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
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 |
|---|---|---|
| Vitamin D (D3, cholecalciferol)Also: Bio Vinci Mega D-vitaminWeek 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets) | Dietary supplement | Vitamin D (D3, cholecalciferol) |
| Placebo (cellulose)Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily | Dietary supplement | Placebo (cellulose) |
Primary outcome
Withdrawal from rehabilitation.
Time frame: 24 weeks
Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks.
Improvement in walking distance
Time frame: 24 weeks
Change in walking distance from week 0 to week 24. Exercise capacity is evaluated using paced walking (Incremental Shuttle Walk Test(ISWT) and Endurance Shuttle Walk Test (ESWT)).
10 secondary outcomes
Change in vitamin D status.
Time frame: 52 weeks
Change in calcium metabolic status.
Time frame: 52 weeks
Change in quality of life.
Time frame: 52 weeks
Change in status of bone metabolism.
Time frame: 52 weeks
Change in walking distance.
Time frame: 52 weeks
Change in fat mass and fat free mass.
Time frame: 52 weeks
Change in physical activity.
Time frame: 24 weeks
COPD exacerbations.
Time frame: 52 weeks
All cause hospital admissions.
Time frame: 52 weeks
All cause mortality.
Time frame: 52 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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.
Jørgen Vestbo, DMSc principal investigator
Hvidovre Universityl Hospital
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 Vitamin D (D3, cholecalciferol) in people with Chronic Obstructive Lung Disease, run by Jorgen Vestbo at 2 sites in Denmark.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 9 Apr 2013. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Withdrawal from rehabilitation. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2013.