NCT01183962

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

August 17, 2010

Last Update Submit

August 3, 2011

Conditions

Coronary Artery DiseaseCardiovascular Disease

Keywords

CADVitamin DCVD

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10

    1 year

Study Arms (2)

Vitamin D

OTHER

Subject receives daily dose of Vitamin D

Dietary Supplement: Vitamin D

No medicine

OTHER

Subject does not receive medication

Other: No medication

Interventions

Vitamin DDIETARY_SUPPLEMENT

Vitamin D 3000 IU daily

Vitamin D
No medicationOTHER

No intervention

No medicine

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 30 and 80 years
  • have a history of medically treated coronary artery disease

You may not qualify if:

  • history of smoking in the past 2 years
  • history of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael DelCore, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(1)