A Phase 2 interventional study of L-Glutamine in Pulmonary Hypertension, Sickle Cell Disease and Thalassemia, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by UCSF Benioff Children's Hospital Oakland · Phase 2, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's enrollment of 13 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks
Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
Time frame: 8 weeks
Plasma Glutamine
Time frame: 8 weeks
Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography
Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second.
Time frame: 8 week
6 Minute Walk Distance
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.
Time frame: 8 weeks
Liver Function Tests
Alanine aminotransferase (ALT) Aspartate aminotransferase (AST)
Time frame: 8 weeks
Renal Function Tests
Creatinine Blood urea nitrogen (BUN)
Time frame: 8 weeks
| Milestone | Treatment: L-glutamine |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
| Ratio | Treatment: L-glutamine |
|---|---|
| Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks | 2.40 ± 1.6 |
| µmol/L | Treatment: L-glutamine |
|---|---|
| Plasma Glutamine | 685.8 ± 139 |
Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second.
| Meters per second | Treatment: L-glutamine |
|---|---|
| Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography | 2.8 ± 0.5 |
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.
| Meters | Treatment: L-glutamine |
|---|---|
| 6 Minute Walk Distance | 366 ± 109 |
Alanine aminotransferase (ALT) Aspartate aminotransferase (AST)
| U/L | Treatment: L-glutamine |
|---|---|
| ALT | 38 ± 27 |
| AST | 63 ± 26 |
Creatinine Blood urea nitrogen (BUN)
| mg/dL | Treatment: L-glutamine |
|---|---|
| Creatinine | 0.9 ± 0.3 |
| BUN | 17 ± 7 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment: L-glutamine | 1/13 (7.7%) | 4/13 (30.8%) | 1/13 (7.7%) |
| Event | Treatment: L-glutamine |
|---|---|
| PainGeneral disorders | 3/13 |
| Acute Chest SyndromeGeneral disorders | 1/13 |
| SepsisInfections and infestations | 1/13 |
| Event | Treatment: L-glutamine |
|---|---|
| Sexually Transmitted Disease Related PainReproductive system and breast disorders | 1/13 |
| Age, Continuous(years) | Treatment: L-glutamine |
|---|---|
| Mean | 45.8 ± 13.8 |
| Sex: Female, Male(Participants) | Treatment: L-glutamine |
|---|---|
| Female | 8 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Treatment: L-glutamine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 13 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment: L-glutamine |
|---|---|
| United States | 13 |
| Erythrocyte Glutamine/Glutamate Ratio(Ratio) | Treatment: L-glutamine |
|---|---|
| Mean | 1.75 ± 0.6 |
| Plasma Glutamine(µmol/L) | Treatment: L-glutamine |
|---|---|
| Mean | 704.5 ± 137 |
| Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography(Meters per second) | Treatment: L-glutamine |
|---|---|
| Mean | 3.0 ± 0.6 |
| 6 Minute Walk Distance(Meters) | Treatment: L-glutamine |
|---|---|
| Mean | 386 ± 94 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glutamine
UCSF Benioff Children's Hospital Oakland