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Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Not Applicable
Terminated
Conditions
Coronary Artery Disease
Cardiovascular Disease
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

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
Primary Outcome Measures
NameTimeMethod
increase in T-regulatory Cells1 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
NameTimeMethod
decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-101 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

πŸ‡ΊπŸ‡Έ

Omaha, Nebraska, United States

The Cardiac Center at Creighton University
πŸ‡ΊπŸ‡ΈOmaha, Nebraska, United States

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