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The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.
A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients > 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental | Nutritional supplement |
|
| placebo | Placebo Comparator | Weekly placebo plus 800 calcium daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak VO2 | Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity | change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Leg Proximal Muscle Strength | Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension | change from baseline to 6 months |
| 6 Minute Walk Distance |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Aldosterone | Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. | change from baseline to 6 months |
| Plasma Renin Activity | Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Boxer, MD | Case Western Reserve Univerity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals/Case Medical Center | Cleveland | Ohio | 44106 | United States |
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recruitment May 2007-April 2011 outpatient heart failure and cardiology clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecalciferol + Calcium | Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months |
| FG001 | Placebo +Calcium | Cholecalciferol : Placebo weekly for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholecalciferol + Calcium | Participants received vitamin D |
| BG001 | Placebo + Calcium | Participants received placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Peak VO2 | Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity | Posted | Mean | Standard Deviation | ml/kg/min | change from baseline to 6 months |
|
|
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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 | Cholecalciferol + Calcium | Nutritional supplement Cholecalciferol : 50,000 IU weekly for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Compliance Officer | Case Western Reserve University | 216-368-0134 | kav6@case.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cholecalciferol | Dietary Supplement | Weekly placebo plus 800 calcium alone |
|
The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL).
| Change from baseline to 6 months |
| Timed Get Up and Go | stand from chair walk 3 meters, return to chair and sit | Change from baseline to 6 months |
| change in renin from baseline to 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Leg Proximal Muscle Strength | Strength of the proximal lower extremity muscles measured by peak torque Nm/kg adjusted for body weight in flexion and extension | Posted | Mean | Standard Deviation | newton-meters/kg | change from baseline to 6 months |
|
|
|
| Secondary | 6 Minute Walk Distance | The six-minute walk test is a reliable and valid test of aerobic capacity, predictive of morbidity and mortality outcome, and correlates with Activity of Daily Living (ADL) and Quality of Living (QOL). | Posted | Mean | Standard Deviation | meters | Change from baseline to 6 months |
|
|
|
| Secondary | Timed Get Up and Go | stand from chair walk 3 meters, return to chair and sit | Posted | Mean | Standard Deviation | seconds | Change from baseline to 6 months |
|
|
|
| Other Pre-specified | Serum Aldosterone | Serum for aldosterone will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. | Posted | Mean | Standard Deviation | ng/dl | change from baseline to 6 months |
|
|
|
| Other Pre-specified | Plasma Renin Activity | Serum for renin will be drawn at baseline, 3, and 6 months, and processed according to lab protocol. | Posted | Mean | Standard Deviation | ng/ml/hr | change in renin from baseline to 6 months |
|
|
|
| 3 |
| 31 |
| 0 |
| 31 |
| EG001 | Placebo +Calcium | Cholecalciferol : Placebo weekly for 6 months | 0 | 33 | 0 | 33 |
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |