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slow enrollment, funding ended
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The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Other | Subject receives daily dose of Vitamin D |
|
| No medicine | Other | Subject does not receive medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Vitamin D 3000 IU daily |
| |
| No medication |
| Measure | Description | Time Frame |
|---|---|---|
| increase in T-regulatory Cells | We expect significant improvement in the suppressive capacity, with or without increase in the number, of circulating T-regs after vitamin D supplementation. This increase in T-regs function will correlate with improvement in clinical parameters. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10 | We also expect that vitamin D supplementation will decrease the levels of pro-inflammatory cytokines and sTNFR1 and increase the level of serum IL-10 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael DelCore, MD | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cardiac Center at Creighton University | Omaha | Nebraska | 68131 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Other |
No intervention |
|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |