NCT00010725

Brief Summary

The purpose of this study is to compare an herbal supplement, nonfood-derived vitamins, and placebo for the care of cardiovascular disease in high risk older African Americans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for phase_2 cardiovascular-diseases

Timeline
Completed

Started Sep 1999

Longer than 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

Study Start

First participant enrolled

September 1, 1999

Completed
1.4 years until next milestone

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
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

First QC Date

February 2, 2001

Last Update Submit

January 11, 2010

Conditions

Cardiovascular Diseases

Keywords

CVD

Interventions

MAKDRUG
Vitamin SupplementsDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American (self-identified)
  • Atherosclerotic coronary heart disease (CHD)defined by documented clinical history of myocardial infarction, coronary revascularization procedure (CABG, PTCA), or coronary angiography demonstrating at least one coronary artery with \>50% stenosis
  • High risk for CVD, defined as \>=2 on Framingham/ATP III risk factor scale
  • Informed consent
  • Written permission of participant's referring physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Howard University Medical Center

Washington D.C., District of Columbia, United States

Location

Maharishi University of Management

Fairfield, Iowa, 52557, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Geritol

Study Officials

  • Robert H. Schneider

    Center for Health and Aging Studies

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 5, 2001

Study Start

September 1, 1999

Study Completion

August 1, 2004

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

US(2)