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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
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 14, 2010
Results First Submitted Date  ICMJE April 20, 2021
Results First Posted Date  ICMJE June 10, 2021
Last Update Posted Date June 10, 2021
Study Start Date  ICMJE March 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks [ Time Frame: 8 weeks ]
Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
Change in erythrocyte glutamine/glutamate ratio, a novel biomarker of oxidative stress, hemolysis and PH post therapy compared to pre-therapy steady-state values. [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
Official Title  ICMJE Phase 2 Trial for Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Hypertension
  • Sickle Cell Disease
  • Thalassemia
Intervention  ICMJE Drug: L-Glutamine
Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.
Study Arms  ICMJE Experimental: Treatment: L-glutamine
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
Intervention: Drug: L-Glutamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2010)
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01048905
Other Study ID Numbers  ICMJE 1R01FD003531-01( U.S. FDA Grant/Contract )
IRB 2008-059 ( Other Identifier: Institutional Review Board )
1R01FD003531-01 ( U.S. FDA Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UCSF Benioff Children's Hospital Oakland
Original Responsible Party Claudia Morris, MD, Children's Hospital & Research Center Oakland
Current Study Sponsor  ICMJE UCSF Benioff Children's Hospital Oakland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Food and Drug Administration (FDA)
Investigators  ICMJE
Principal Investigator: Claudia Morris, MD Emory University
Principal Investigator: Augusta Saulys, MD Children's Hosptial & Research Center Oakland
PRS Account UCSF Benioff Children's Hospital Oakland
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP