Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
UCSF Benioff Children’s Hospital Oakland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography > 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Sickle Cell Disease Thalassemia Drug: L-Glutamine Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Pharmacokinetics
8 hour pharmacokinetics after glutamine supplementation
 Drug: L-Glutamine
Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
Experimental: Treatment
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
 Drug: L-Glutamine
Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in erythrocyte glutamine/glutamate ratio, a novel biomarker of oxidative stress,post therapy compared to pre-therapy steady-state values. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Plasma Glutamine [ Time Frame: 8 weeks ]
  2. Tricuspid Regurgitant Jet velocity on Doppler Echocardiography [ Time Frame: 8 week ]
  3. 6 minute walk distance [ Time Frame: 8 weeks ]
  4. Liver function tests [ Time Frame: 8 weeks ]
  5. Renal function tests [ Time Frame: 8 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal
  • PH documented by echocardiography, defined as at TRV greater than 2.5 m/s
  • Age greater than or equal to 4 years

Exclusion Criteria:

  • Inability to take or tolerate oral medication
  • Acute crisis or hospitalization within 1 month of enrollment
  • Hepatic dysfunction (SGPT greater than 3X normal)
  • Renal dysfunction (Creatinine greater than 2X normal)
  • Allergy to glutamine
  • Pregnancy or breastfeeding
  • Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein supplements (other therapies acceptable if stable more than 3 months)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94608
Sponsors and Collaborators
UCSF Benioff Children’s Hospital Oakland
Investigators
Layout table for investigator information
Principal Investigator: Claudia Morris, MD Emory University
Principal Investigator: Augusta Saulys, MD Children's Hosptial & Research Center Oakland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: UCSF Benioff Children’s Hospital Oakland
ClinicalTrials.gov Identifier: NCT01048905    
Other Study ID Numbers: 1R01FD003531-01 ( U.S. FDA Grant/Contract )
IRB 2008-059
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Keywords provided by UCSF Benioff Children’s Hospital Oakland:
Pulmonary Hypertension
Sickle Cell Disease
Thalassemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Hypertension
Anemia, Sickle Cell
Thalassemia
Hemolysis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes