Vitamin D Repletion in Coronary Artery Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vitamin D Deficiency Coronary Artery Disease Endothelial Dysfunction Inflammation |
Drug: Ergocalciferol Other: Sugar pill |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease |
- Endothelial function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry
- Inflammation [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in blood levels of hs-CRP, interleukin-12, interferon-gamma, CXCL-10, e-selectin, s-VCAM, s-ICAM
| Enrollment: | 90 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
|
Drug: Ergocalciferol
Oral capsule, 50,000 units, once a week, 12 weeks
|
| Placebo Comparator: Sugar pill |
Other: Sugar pill
Oral capsule, once a week, 12 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Exclusion Criteria:
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
- cardiogenic shock at time of presentation
- current planned or emergent CABG
- prior gastric or small bowel surgery
- pancreatitis
- malabsorption
- inflammatory bowel disease
- autoimmune disease
- active malignancy
- current use of > 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Contacts and Locations| United States, New York | |
| Jacobi Medical Center | |
| Bronx, New York, United States, 10461 | |
| Montefiore Medical Center / Weiler division | |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: | Seth I Sokol, MD | Jacobi Medical Center |
More Information
No publications provided
| Responsible Party: | Seth I. Sokol, M.D., Principal Investigator, New York City Health and Hospitals Corporation |
| ClinicalTrials.gov Identifier: | NCT01570309 History of Changes |
| Other Study ID Numbers: | AHA Award #0885041N |
| Study First Received: | March 26, 2012 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York City Health and Hospitals Corporation:
|
vitamin D, vitamin D deficiency coronary artery disease ergocalciferol endothelial function adhesion molecules inflammation |
IL-12 interferon-gamma CXCL-10 reactive hyperemia peripheral arterial tonometry endothelial dysfunction cytokines chemokines |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Inflammation Vitamin D Deficiency Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013