Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
|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: NCT01048905|
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : June 10, 2021
Last Update Posted : June 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Sickle Cell Disease Thalassemia||Drug: L-Glutamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial for Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Treatment: L-glutamine
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
- Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks [ Time Frame: 8 weeks ]Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
- Plasma Glutamine [ Time Frame: 8 weeks ]
- Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography [ Time Frame: 8 week ]Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second.
- 6 Minute Walk Distance [ Time Frame: 8 weeks ]The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface.
- Liver Function Tests [ Time Frame: 8 weeks ]Alanine aminotransferase (ALT) Aspartate aminotransferase (AST)
- Renal Function Tests [ Time Frame: 8 weeks ]Creatinine Blood urea nitrogen (BUN)
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): NCT01048905
|United States, California|
|Children's Hospital & Research Center Oakland|
|Oakland, California, United States, 94608|
|Principal Investigator:||Claudia Morris, MD||Emory University|
|Principal Investigator:||Augusta Saulys, MD||Children's Hosptial & Research Center Oakland|