Prospective L-arginine Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01485757|
Recruitment Status : Terminated (Technical difficulty with Endo-PAT machine)
First Posted : December 5, 2011
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant||Drug: L-arginine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).
- Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. [ Time Frame: baseline and 12 weeks ]Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period.
- Change from baseline in serum levels of oxidative stress markers [ Time Frame: baseline and 12 weeks ]Serum markers of oxidative stress will be measured at baseline and after a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.
- Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine [ Time Frame: baseline and 12 weeks ]Exercise tolerance will be assessed with a 6 minute walk at baseline and following a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485757
|United States, Michigan|
|University of Michigan Pediatric Heart Transplant Clinic|
|Ann Arbor, Michigan, United States, 48109|