NCT00010699

Brief Summary

The primary aim of the present study is to test the effect of alpha-tocopherol supplementation on the progression of carotid atherosclerosis in patients with coronary artery disease

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

First QC Date

February 2, 2001

Last Update Submit

March 21, 2013

Conditions

Keywords

cvd

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be on the American Heart Association Phase II diet and a HMG CoA reductase inhibitor for at least one year
  • Have an LDL cholesterol \<125 mg/dL on 2 visits at least 4 weeks apart during the 10 month lead in phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California Davis Medical Center

Sacramento, California, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Vitamin E

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ishwarlal Jialal, MD, Ph.D.

    Department of Pathology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations