Vitamin D and T-Regulatory Cells in Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183962
Recruitment Status : Terminated (slow enrollment, funding ended)
First Posted : August 18, 2010
Last Update Posted : August 4, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Cardiovascular Disease Dietary Supplement: Vitamin D Other: No medication Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and T-Regulatory Cells in Coronary Artery Disease
Study Start Date : February 2010
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Vitamin D
Subject receives daily dose of Vitamin D
Dietary Supplement: Vitamin D
Vitamin D 3000 IU daily
No medicine
Subject does not receive medication
Other: No medication
No intervention

Primary Outcome Measures :
  1. increase in T-regulatory Cells [ Time Frame: 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 :
  1. decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01183962

United States, Nebraska
The Cardiac Center at Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Michael DelCore, MD Creighton University

Responsible Party: Michael Del Core, MD, Creighton University Identifier: NCT01183962     History of Changes
Other Study ID Numbers: 09-15602
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Creighton University:
Vitamin D

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents