Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2011-09-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin D (D3, cholecalciferol)
Vitamin D (D3, cholecalciferol)
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
Placebo (cellulose)
Placebo (cellulose)
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
Interventions
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Vitamin D (D3, cholecalciferol)
Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
Placebo (cellulose)
Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed COPD with forced expiratory volume in 1 second (FEV1) \< 50 % of predicted
* Breathlessness relative to MRC dyspnoea grade 3 or more
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Jorgen Vestbo
OTHER
Responsible Party
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Jorgen Vestbo
Prof. DMSc
Principal Investigators
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Jørgen Vestbo, DMSc
Role: PRINCIPAL_INVESTIGATOR
Hvidovre Universityl Hospital
Locations
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Hvidovre University Hospital, Department of Respiratory Medicine
Hvidovre, , Denmark
Medical Unit, Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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DvitKOL01022011
Identifier Type: -
Identifier Source: org_study_id
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