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The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Cholecalciferol (2000 I.U. daily) |
|
| Placebo | Placebo Comparator | Placebo capsule (sugar pill daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (cholecalciferol) | Dietary Supplement | 2000 I.U. daily for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score | SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken M. Kunisaki, M.D. | Minneapolis Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | United States |
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Participants from the Minneapolis Veterans Affairs Health Care System were recruited as a convenience sample between January 2009 and October 2011 from outpatient pulmonary clinics and an institutional review board-approved database of patients with COPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo : Placebo (sugar pill) daily for 6 weeks |
| FG001 | Vitamin D | Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Dietary Supplement |
Placebo (sugar pill) daily for 6 weeks |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo : Placebo (sugar pill) daily for 6 weeks |
| BG001 | Vitamin D | Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Short Physical Performance Battery (SPPB) Score | SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks |
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| Secondary | Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | 25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo : Placebo (sugar pill) daily for 6 weeks | 0 | 20 | 0 | 20 | ||
| EG001 | Vitamin D | Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Kunisaki, M.D. | Minneapolis VA Health Care System | 612-467-4400 | kunis001@umn.edu |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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| Male |
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