Trial · NCT00131508
Trial of Oral Glutamine in Patients With Sickle Cell Anemia
NCT00131508, Phase 2, Terminated, St. Jude Children's Research Hospital; results first posted 2010-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Oral Glutamine in Patients With Sickle Cell Anemia. Trials, record NCT00131508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00131508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Oral Glutamine in Patients With Sickle Cell Anemia
- NCT number
- NCT00131508
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Anemia, Sickle Cell
- Interventions
- Glutamine, Placebo
- First posted
- 2005-08-18
- Last updated
- 2017-04-26
- Results first posted
- 2010-05-12
- Limitations and caveats
The study was designed to enroll 46 participants (23 per arm). Due to slow accrual the study was terminated after enrolling 27 participants. Of the 27 participants enrolled, 2 dropped out of the study prior to randomization.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Resting Energy Expenditure From Baseline to 12 Months | Baseline and 12 months | To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio. |
| Secondary | Change in Body Mass Index From Baseline to 12 Months | Baseline and 12 months | To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups. |
| Secondary | Change in Red Blood Cell Glutamine From Baseline to 12 Months | Baseline and 12 months | To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups. |
| Secondary | Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Baseline and 12 Months | Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life. |
| Secondary | Change in Height Z-score From Baseline to 12 Months | Baseline and 12 months | To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment. |
| Secondary | Change in Height Percentile From Baseline to 12 Months | Baseline and 12 months | To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment. |
| Secondary | Change in Weight Percentile From Baseline to 12 Months | Basline and 12 months | To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment. |
| Secondary | Change in Pulse Rate From Baseline to 12 Months | Baseline and 12 months | To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups. |
| Secondary | Change in Hand Grip From Baseline to 12 Months. | Baseline and 12 months | To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups. Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Resting Energy Expenditure From Baseline to 12 Months | Baseline and 12 months | REE ratio | MEDIAN | |
| SECONDARY | Change in Body Mass Index From Baseline to 12 Months | Baseline and 12 months | kg/m2 | MEDIAN | |
| SECONDARY | Change in Red Blood Cell Glutamine From Baseline to 12 Months | Baseline and 12 months | nmol/mg creatinine | MEDIAN | |
| SECONDARY | Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Baseline and 12 Months | Units on a scale | MEDIAN | |
| SECONDARY | Change in Height Z-score From Baseline to 12 Months | Baseline and 12 months | Analyzed patients had a height measurement at both baseline and 12 months. | Z-score | MEDIAN |
| SECONDARY | Change in Height Percentile From Baseline to 12 Months | Baseline and 12 months | Analyzed patients had a height measurement at both baseline and 12 months. | Percentile | MEDIAN |
| SECONDARY | Change in Weight Percentile From Baseline to 12 Months | Basline and 12 months | Analyzed patients had a height measurement at both baseline and 12 months. | Percentile | MEDIAN |
| SECONDARY | Change in Pulse Rate From Baseline to 12 Months | Baseline and 12 months | Analyzed patients had a height measurement at both baseline and 12 months. | Beats per minute (BPM) | MEDIAN |
| SECONDARY | Change in Hand Grip From Baseline to 12 Months. | Baseline and 12 months | Analyzed patients had a height measurement at both baseline and 12 months. | kg | MEDIAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Resting Energy Expenditure From Baseline to 12 Months | Placebo | -5.5 | Full Range -37.6 to 12.2 | REE ratio | |
| Change in Resting Energy Expenditure From Baseline to 12 Months | Glutamine | 7.1 | Full Range -9.0 to 41.3 | REE ratio | |
| Change in Body Mass Index From Baseline to 12 Months | Placebo | 0.1 | Full Range -0.3 to 1.2 | kg/m2 | |
| Change in Body Mass Index From Baseline to 12 Months | Glutamine | 0.8 | Full Range -0.6 to 0.9 | kg/m2 | |
| Change in Red Blood Cell Glutamine From Baseline to 12 Months | Placebo | 43.5 | Full Range -173.9 to 137.0 | nmol/mg creatinine | |
| Change in Red Blood Cell Glutamine From Baseline to 12 Months | Glutamine | 100.8 | Full Range 21.1 to 262.4 | nmol/mg creatinine | |
| Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Placebo | Baseline Parent Reported Physical Function | 1.4 | Full Range 0.3 to 3.5 | Units on a scale |
| Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Glutamine | Baseline Parent Reported Physical Function | 2.0 | Full Range 0.0 to 2.9 | Units on a scale |
| Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Placebo | Baseline Parent Reported Emotional Function | 1.0 | Full Range 0.0 to 2.0 | Units on a scale |
| Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports. | Glutamine | Baseline Parent Reported Emotional Function | 2.0 | Full Range 0.0 to 4.0 | Units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | Glutamine | 13 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | COMPLETED | Glutamine | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Glutamine | 8 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Glutamine | ||
| Total, other adverse events | Placebo | 0 | 12 |
| Total, other adverse events | Glutamine | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Glutamine | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Glutamine vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00131508
GET https://conductscience.org/api/trials/v1/NCT00131508/results?page=2