Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01183962
• Other study ID #: 09-15602
• Status: Terminated
• Phase: N/A
• First received: August 17, 2010
• Last updated: August 3, 2011
• Start date: February 2010

Study information

• Verified date: August 2011
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• Vitamin D
Vitamin D 3000 IU daily

Other:
• No medication
No intervention

Locations

Country	Name	City	State
United States	The Cardiac Center at Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in T-regulatory Cells	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.	1 year	No
Secondary	decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10	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	1 year	No