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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.
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The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D (D3, cholecalciferol) | Active Comparator |
| |
| Placebo (cellulose) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (D3, cholecalciferol) | Dietary Supplement | Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal from rehabilitation. | Withdrawal will be defined as giving up rehabilitation or delaying any training visit by more than 3 weeks. | 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)). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D status. | se-25-OHD se-PTH | 52 weeks |
| Change in calcium metabolic status. | se-calcium se-phosphate se-magnesium | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jørgen Vestbo, DMSc | Hvidovre Universityl Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital, Department of Respiratory Medicine | Hvidovre | 2650 | Denmark | |||
| Medical Unit, Hvidovre University Hospital |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo (cellulose) | Dietary Supplement | Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily |
|
| Change in quality of life. | COPD Assessment Test (CAT) and St George Respiratory Questionnaire (SGRQ). | 52 weeks |
| Change in status of bone metabolism. | DXA (Dual energy X-ray Absorptiometry) scans | 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)). | 52 weeks |
| Change in fat mass and fat free mass. | Whole body DXA scans. | 52 weeks |
| Change in physical activity. | Physical activity at home is measured over a week using an activity sensor (SenseWear Pro armband). | 24 weeks |
| COPD exacerbations. | 52 weeks |
| All cause hospital admissions. | 52 weeks |
| All cause mortality. | 52 weeks. |
| Hvidovre |
| 2650 |
| Denmark |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |