Trial · NCT01048905
Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
NCT01048905, Phase 2, Completed, UCSF Benioff Children's Hospital Oakland; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension. Trials, record NCT01048905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01048905
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension
- NCT number
- NCT01048905
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Conditions
- Pulmonary Hypertension, Sickle Cell Disease, Thalassemia
- Interventions
- L-Glutamine
- First posted
- 2010-01-14
- Last updated
- 2021-06-10
- Results first posted
- 2021-06-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks | 8 weeks | Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress |
| Secondary | Plasma Glutamine | 8 weeks | |
| Secondary | Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography | 8 week | Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second. |
| Secondary | 6 Minute Walk Distance | 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. |
| Secondary | Liver Function Tests | 8 weeks | Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) |
| Secondary | Renal Function Tests | 8 weeks | Creatinine Blood urea nitrogen (BUN) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks | 8 weeks | Blood work only available for N=6 participants, as reported here. | Ratio | MEAN |
| SECONDARY | Plasma Glutamine | 8 weeks | µmol/L | MEAN | |
| SECONDARY | Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography | 8 week | Data available for 11 participants only because one patient missed their appointment for their week 8 echocardiogram and was lost to follow up, and another patient died of sepsis before week 8 visit. | Meters per second | MEAN |
| SECONDARY | 6 Minute Walk Distance | 8 weeks | Meters | MEAN | |
| SECONDARY | Liver Function Tests | 8 weeks | U/L | MEAN | |
| SECONDARY | Renal Function Tests | 8 weeks | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks | Treatment: L-glutamine | 2.40 | Standard Deviation 1.6 | Ratio | |
| Plasma Glutamine | Treatment: L-glutamine | 685.8 | Standard Deviation 139 | µmol/L | |
| Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography | Treatment: L-glutamine | 2.8 | Standard Deviation 0.5 | Meters per second | |
| 6 Minute Walk Distance | Treatment: L-glutamine | 366 | Standard Deviation 109 | Meters | |
| Liver Function Tests | Treatment: L-glutamine | ALT | 38 | Standard Deviation 27 | U/L |
| Liver Function Tests | Treatment: L-glutamine | AST | 63 | Standard Deviation 26 | U/L |
| Renal Function Tests | Treatment: L-glutamine | Creatinine | 0.9 | Standard Deviation 0.3 | mg/dL |
| Renal Function Tests | Treatment: L-glutamine | BUN | 17 | Standard Deviation 7 | mg/dL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment: L-glutamine | 13 | |
| Overall Study | COMPLETED | Treatment: L-glutamine | 12 | |
| Overall Study | NOT COMPLETED | Treatment: L-glutamine | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sexually Transmitted Disease Related Pain | Reproductive system and breast disorders | Treatment: L-glutamine | 1 | 13 | |
| serious | Pain | General disorders | Treatment: L-glutamine | 3 | 13 | |
| serious | Acute Chest Syndrome | General disorders | Treatment: L-glutamine | 1 | 13 | |
| serious | Sepsis | Infections and infestations | Treatment: L-glutamine | 1 | 13 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment: L-glutamine | 1 | 13 |
| Total, other adverse events | Treatment: L-glutamine | 1 | 13 |
| Total, serious adverse events | Treatment: L-glutamine | 4 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD003531 | Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension | MORRIS, CLAUDIA R | CHILDREN'S HOSPITAL & RES CTR AT OAKLAND | FOOD AND DRUG ADMINISTRATION | 2009 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01048905
GET https://conductscience.org/api/trials/v1/NCT01048905/registered