Vitamin D and T-Regulatory Cells in Coronary Artery Disease

NCT ID: NCT01183962

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vitamin D

Subject receives daily dose of Vitamin D

Group Type OTHER

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D 3000 IU daily

No medicine

Subject does not receive medication

Group Type OTHER

No medication

Intervention Type OTHER

No intervention

Interventions

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Vitamin D

Vitamin D 3000 IU daily

Intervention Type DIETARY_SUPPLEMENT

No medication

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Michael DelCore, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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The Cardiac Center at Creighton University

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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09-15602

Identifier Type: -

Identifier Source: org_study_id

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