Vitamin D Repletion in Coronary Artery Disease

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.

Conditions

• Vitamin D Deficiency
• Coronary Artery Disease
• Endothelial Dysfunction
• Inflammation

Interventions

DRUG

Ergocalciferol

Oral capsule, 50,000 units, once a week, 12 weeks

OTHER

Sugar pill

Oral capsule, once a week, 12 weeks

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Jacobi Medical Center

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Yale University

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Seth I. Sokol, M.D.

  lead OTHER

Principal Investigators

• Seth I Sokol, MD · Jacobi Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States

Study Locations