Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
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ClinicalTrials.gov Identifier: NCT01048905 |
Recruitment Status :
Completed
First Posted : January 14, 2010
Last Update Posted : July 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension Sickle Cell Disease Thalassemia | Drug: L-Glutamine | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Pharmacokinetics
8 hour pharmacokinetics after glutamine supplementation
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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. |
- 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 ]
- Plasma Glutamine [ Time Frame: 8 weeks ]
- Tricuspid Regurgitant Jet velocity on Doppler Echocardiography [ Time Frame: 8 week ]
- 6 minute walk distance [ Time Frame: 8 weeks ]
- Liver function tests [ Time Frame: 8 weeks ]
- Renal function tests [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

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 |
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 |
Pulmonary Hypertension Sickle Cell Disease Thalassemia |
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 |