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The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D (cholecalciferol) | Active Comparator | Subjects receive 150,000 IU of Vitamin D3 every 2 months |
|
| Placebo | Placebo Comparator | Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | cholecalciferol 150,000 IU by mouth every 2 months for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml. | 1 year | |
| To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To see if higher serum 25(OH) D levels will help in better control of blood pressure. | 1 year | |
| To perform proteomics analysis to: a) Extract total protein; b) Profile protein expression in 2-DE and /or 2-DLC and direct mass spectrometric analysis (dMS) on the serum of vitamin D supplemented and placebo subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Armas, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cardiac Center at Creighton University | Omaha | Nebraska | 68131 | United States | ||
| University of Nebraska Medical Center |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Dietary Supplement | placebo by mouth every 2 months for 1 year |
|
| 1 year |
| To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects. | 1 year |
| To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease | 1 year |
| Omaha |
| Nebraska |
| 68198 |
| United States |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |