Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Cardiovascular Disease
• Interventions: Dietary Supplement: Vitamin D; Other: No medication

• Registration Number: NCT01183962
• Lead Sponsor: Creighton University

Brief Summary

The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• between the ages of 30 and 80 years
• have a history of medically treated coronary artery disease

Exclusion Criteria

• history of smoking in the past 2 years
• history of diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	Subject receives daily dose of Vitamin D
No medicine	No medication	Subject does not receive medication

Primary Outcome Measures

Name	Time	Method
increase in T-regulatory Cells	1 year	We expect significant improvement in the suppressive capacity, with or without increase in the number, of circulating T-regs after vitamin D supplementation. This increase in T-regs function will correlate with improvement in clinical parameters.

Secondary Outcome Measures

Name	Time	Method
decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10	1 year	We also expect that vitamin D supplementation will decrease the levels of pro-inflammatory cytokines and sTNFR1 and increase the level of serum IL-10

Trial Locations

Locations (1)

The Cardiac Center at Creighton University; 🇺🇸 Omaha, Nebraska, United States