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NCT00131508 · ClinicalTrials.gov registry record · Phase 2
Trial of Oral Glutamine in Patients With Sickle Cell Anemia
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00131508: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT00131508 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00131508, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do not have the disease. This may be the reason why children and teenagers with sickle cell anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens that do not have the disease. This study is being done to find out if giving a supplement called glutamine will help children with sickle cell anemia by lowering their energy needs and improving their growth and strength. Children will be randomly assigned (like a flip of a coin) to one of two groups. One group will take glutamine and one group will take a placebo (a protein mixture that looks like glutamine but may not have the same effect in the body). No one will know which group is taking which supplement until the study has been completed. Children will be in the study for 12 months.
Primary Outcome
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 un
Interventions
- DRUG Placebo
- DRUG Glutamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2004-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
Why NCT00131508 stopped before completion
NCT00131508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00131508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00131508 about?
NCT00131508 is a clinical study titled "Trial of Oral Glutamine in Patients With Sickle Cell Anemia". Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do not have the disease. This may be the reason why children and teenagers with sickle cell anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens that do not have the disea...
What is the current status of trial NCT00131508?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2004-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00131508?
The interventions under investigation include: Placebo (DRUG), Glutamine (DRUG).
Who is sponsoring clinical trial NCT00131508?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00131508's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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