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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Jacobi Medical Center | OTHER |
| Albert Einstein College of Medicine | OTHER |
| Yale University |
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Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergocalciferol | Active Comparator | 50,000 units of ergocalciferol once a week for 12 weeks |
|
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol | Drug | Oral capsule, 50,000 units, once a week, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function | Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented. | Baseline and 12 weeks |
| Inflammation - | Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups | Baseline and 12 weeks |
| Inflammation | Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups | Baseline to 12 weeks |
| Inflammation | Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups | Baseline to 12 weeks |
| Inflammation | Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups | Baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth I Sokol, MD | Jacobi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center / Weiler division |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23184900 | Result | Sokol SI, Srinivas V, Crandall JP, Kim M, Tellides G, Lebastchi AH, Yu Y, Gupta AK, Alderman MH. The effects of vitamin D repletion on endothelial function and inflammation in patients with coronary artery disease. Vasc Med. 2012 Dec;17(6):394-404. doi: 10.1177/1358863X12466709. |
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Subjects with ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization, were screened for vitamin D deficiency by measurement of serum 25-hydroxyvitamin D (25-vitamin D).Eligible subjects with a 25-vitamin D level < 20 ng/ml were randomly assigned 1:1 to active or placebo treatment
Recruitment from October 2008 through December 2010 from the cardiac catheterization laboratories and outpatient clinics of the Jacobi Medical Center and Montefiore Medical Center in the Northeastern section of the Bronx, NY. Additional recruitment occurred at Crystal Run Health in Orange County, NY.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergocalciferol | 50,000 units of ergocalciferol once a week for 12 weeks |
| FG001 | Sugar Pill | Matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergocalciferol | 50,000 units of ergocalciferol once a week for 12 weeks |
| BG001 | Sugar Pill | Matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Endothelial Function | Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented. | Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups. | Posted | Median | Inter-Quartile Range | reactive hypermia index | Baseline and 12 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 | Ergocalciferol | 50,000 units of ergocalciferol once a week for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Seth I Sokol | Jacobi Medical Center | 718-918-5735 | seth.sokol@nbhn.net |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| OTHER |
| Montefiore Medical Center | OTHER |
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| Sugar pill |
| Other |
Oral capsule, once a week, 12 weeks |
|
| The Bronx |
| New York |
| 10461 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
50,000 units of ergocalciferol once a week for 12 weeks
| OG001 | Sugar Pill | Matching placebo |
|
|
| Primary | Inflammation - | Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups | Posted | Median | Inter-Quartile Range | mg/dl | Baseline and 12 weeks |
|
|
|
| Primary | Inflammation | Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups | Posted | Median | Inter-Quartile Range | pg/ml | Baseline to 12 weeks |
|
|
|
| Primary | Inflammation | Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups | Posted | Median | Inter-Quartile Range | pg/ml | Baseline to 12 weeks |
|
|
|
| Primary | Inflammation | Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups | Posted | Median | Inter-Quartile Range | pg/ml | Baseline to week 12 |
|
|
|
| 10 |
| 45 |
| 4 |
| 45 |
| EG001 | Sugar Pill | Matching placebo | 9 | 45 | 4 | 45 |
| Heart failure exacerbation | Cardiac disorders | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| ICD shock inappropriate | Cardiac disorders | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Angina | Cardiac disorders | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Atypical chest pain | Cardiac disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D002241 | Carbohydrates |