Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
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| ClinicalTrials.gov Identifier: NCT01048905 |
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Recruitment Status :
Completed
First Posted : January 14, 2010
Results First Posted : June 10, 2021
Last Update Posted : June 10, 2021
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Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Pulmonary Hypertension Sickle Cell Disease Thalassemia |
| Intervention |
Drug: L-Glutamine |
| Enrollment | 13 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Treatment: L-glutamine |
|---|---|
 Arm/Group Description |
Patients will receive an 8-week course of oral L-glutamine 10 grams TID L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age. |
| Period Title: Overall Study | |
| Started | 13 |
| Completed | 12 |
| Not Completed | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment: L-glutamine | |
|---|---|---|
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Arm/Group Description |
Patients will receive an 8-week course of oral L-glutamine 10 grams TID L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age. |
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| Overall Number of Baseline Participants | 13 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 13 participants | |
| 45.8 (13.8) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 13 participants | |
| Female |
8 61.5%
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| Male |
5 38.5%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 13 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
13 100.0%
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| White |
0 0.0%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 13 participants |
| 13 | ||
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Erythrocyte Glutamine/Glutamate Ratio
[1] Mean (Standard Deviation) Unit of measure: Ratio |
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| Number Analyzed | 6 participants | |
| 1.75 (0.6) | ||
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[1]
Measure Analysis Population Description: Blood work only available for N=6 participants, as reported here.
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Plasma Glutamine
[1] Mean (Standard Deviation) Unit of measure: µmol/L |
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| Number Analyzed | 6 participants | |
| 704.5 (137) | ||
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[1]
Measure Analysis Population Description: Blood work only available for N=6 participants, as reported here.
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Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography
[1] Mean (Standard Deviation) Unit of measure: Meters per second |
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| Number Analyzed | 13 participants | |
| 3.0 (0.6) | ||
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[1]
Measure Description: Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second.
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6 Minute Walk Distance
[1] Mean (Standard Deviation) Unit of measure: Meters |
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| Number Analyzed | 13 participants | |
| 386 (94) | ||
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[1]
Measure Description: 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.
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Liver Function Tests
Mean (Standard Deviation) Unit of measure: U/L |
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| Alanine aminotransferase (ALT) | Number Analyzed | 13 participants |
| 40 (42) | ||
| Aspartate aminotransferase (AST) | Number Analyzed | 13 participants |
| 73 (40) | ||
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Renal Function Tests
Mean (Standard Deviation) Unit of measure: mg/dL |
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| Creatinine | Number Analyzed | 13 participants |
| 0.9 (0.4) | ||
| Blood urea nitrogen (BUN) | Number Analyzed | 13 participants |
| 14 (10) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Claudia R. Morris MD, FAAP |
| Organization: | Emory University School of Medicine |
| Phone: | 404-727-5500 |
| EMail: | claudia.r.morris@emory.edu |
| 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 ( Other Identifier: Institutional Review Board ) 1R01FD003531-01 ( U.S. FDA Grant/Contract ) |
| First Submitted: | January 12, 2010 |
| First Posted: | January 14, 2010 |
| Results First Submitted: | April 20, 2021 |
| Results First Posted: | June 10, 2021 |
| Last Update Posted: | June 10, 2021 |