Back to resultsVitamin D and T-Regulatory Cells in Coronary Artery Disease
Primary Purpose
Coronary Artery Disease, Cardiovascular Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
No medication
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring CAD, Vitamin D, CVD
Eligibility Criteria
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
Sites / Locations
- The Cardiac Center at Creighton University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Vitamin D
No medicine
Arm Description
Subject receives daily dose of Vitamin D
Subject does not receive medication
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01183962
Brief Title
Vitamin D and T-Regulatory Cells in Coronary Artery Disease
Official Title
Vitamin D and T-Regulatory Cells in Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment, funding ended
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiovascular Disease
Keywords
CAD, Vitamin D, CVD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Other
Arm Description
Subject receives daily dose of Vitamin D
Arm Title
No medicine
Arm Type
Other
Arm Description
Subject does not receive medication
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D 3000 IU daily
Intervention Type
Other
Intervention Name(s)
No medication
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
increase in T-regulatory Cells
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael DelCore, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cardiac Center at Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D and T-Regulatory Cells in Coronary Artery Disease
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