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Vitamin D and T-Regulatory Cells in Coronary Artery Disease

This study has been terminated.
(slow enrollment, funding ended)
Sponsor:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT01183962
First received: August 17, 2010
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
Cardiovascular Disease
 Dietary Supplement: Vitamin D
Other: No medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • increase in T-regulatory Cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: February 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183962

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

No publications provided

Responsible Party: Michael Del Core, MD, Creighton University
ClinicalTrials.gov Identifier: NCT01183962     History of Changes
Other Study ID Numbers: 09-15602
Study First Received: August 17, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
CAD
Vitamin D
CVD

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

ClinicalTrials.gov processed this record on October 17, 2012