Vitamin D Repletion in Coronary Artery Disease

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seth I. Sokol, M.D.
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University; American Heart Association; Jacobi Medical Center; Montefiore Medical Center; Yale University
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

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