Vitamin D Repletion in Coronary Artery Disease

Completed · Not applicable

Conditions studied: Vitamin D Deficiency, Coronary Artery Disease, Endothelial Dysfunction, Inflammation

In brief

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.

Key facts

Study ID

NCT01570309

Run by

Seth I. Sokol, M.D.

People needed

96

Starts

2008-08-01

Expected to finish

2011-03-01

Last updated by the study team

2013-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States
• Montefiore Medical Center / Weiler division — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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