Effect of Creatine and L-Arginine on Endothelial Function

NCT ID: NCT00551434

Last Updated: 2007-10-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Creatine

Intervention Type DIETARY_SUPPLEMENT

Creatine 21 g daily

2

Group Type EXPERIMENTAL

l-arginine

Intervention Type DIETARY_SUPPLEMENT

l-arginine 9 g daily

3

Group Type EXPERIMENTAL

L-arginine and creatine

Intervention Type DIETARY_SUPPLEMENT

L-arginine

4

Group Type PLACEBO_COMPARATOR

placebo, double

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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Creatine

Creatine 21 g daily

Intervention Type DIETARY_SUPPLEMENT

L-arginine and creatine

L-arginine

Intervention Type DIETARY_SUPPLEMENT

l-arginine

l-arginine 9 g daily

Intervention Type DIETARY_SUPPLEMENT

placebo, double

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role lead

Principal Investigators

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Joseph A Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Other Identifiers

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H-22852

Identifier Type: -

Identifier Source: org_study_id