Effect of Creatine and L-Arginine on Endothelial Function

October 30, 2007 updated by: Boston University

Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease

The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Coronary artery disease

Exclusion Criteria:

  • Pregnancy
  • Creatine use within one month of study
  • L-arginine use within one month of study
  • Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Dietary supplement: Creatine
Creatine 21 g daily
EXPERIMENTAL: 2
Dietary supplement: l-arginine
l-arginine 9 g daily
EXPERIMENTAL: 3
Dietary supplement: L-arginine and creatine
L-arginine
PLACEBO_COMPARATOR: 4
Dietary supplement: placebo, double
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brachial artery flow-mediated dilation
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
serum arginine, creatine, creatinine, homocysteine
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (ESTIMATE)

October 31, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22852 (Baylor College of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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