Effect of Creatine and L-Arginine on Endothelial Function

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00551434
• Collaborator: (none)
• Enrollment: 119
• Arms: 4
• Duration (Months): 40

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Dietary Supplement: Creatine; Dietary Supplement: L-arginine and creatine; Dietary Supplement: l-arginine; Dietary Supplement: placebo, double	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease
• Study Start Date: Aug 1, 2002
• Actual Study Completion Date: Dec 1, 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Brachial artery flow-mediated dilation [5 days]

Secondary Outcome Measures

1. serum arginine, creatine, creatinine, homocysteine [5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Joseph A Vita, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00551434
• Other Study ID Numbers: H-22852
• First Posted: Oct 31, 2007
• Last Update Posted: Oct 31, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Oct 31, 2007