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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014