Back to resultsEffect of Creatine and L-Arginine on Endothelial Function
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Creatine
L-arginine and creatine
l-arginine
placebo, double
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Brachial artery flow-mediated dilation
Secondary Outcome Measures
serum arginine, creatine, creatinine, homocysteine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551434
Brief Title
Effect of Creatine and L-Arginine on Endothelial Function
Official Title
Effect of Creatine and L-Arginine on Endothelial Function in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Intervention Description
Creatine 21 g daily
Intervention Type
Dietary Supplement
Intervention Name(s)
L-arginine and creatine
Intervention Description
L-arginine
Intervention Type
Dietary Supplement
Intervention Name(s)
l-arginine
Intervention Description
l-arginine 9 g daily
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo, double
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilation
Time Frame
5 days
Secondary Outcome Measure Information:
Title
serum arginine, creatine, creatinine, homocysteine
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Vita, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Creatine and L-Arginine on Endothelial Function
We'll reach out to this number within 24 hrs