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NCT00645879 · ClinicalTrials.gov registry record · Phase 1
Anaplerotic Therapy in Propionic Acidemia
A Phase 1 study of Propionic Acidemia, sponsored by Nicola Longo.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT00645879: Completed Phase 1 study of Propionic Acidemia, sponsored by Nicola Longo.
NCT00645879 is a Phase 1 study of Propionic Acidemia that has completed, run by Nicola Longo. The registered enrollment target is 3 participants, below the 225-participant average among 6 other Propionic Acidemia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645879, a Phase 1 study of Propionic Acidemia, has completed, sponsored by Nicola Longo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this project is to define whether nutritional supplements (ornithine alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients with propionic acidemia. Ornithine alpha-ketoglutarate, glutamine, and citrate are commonly used as nutritional supplements specially by athletes to increase muscle strength. They can be mixed with formula or other foods.
Conditions Studied
Interventions
- DRUG ornithine alpha ketoglutarate
- DRUG glutamine
- DRUG disodium citrate
Study Locations (1)
Utah
- University of Utah, Department of Pediatrics - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00645879 record still lists
NCT00645879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 225-participant average among 6 other Propionic Acidemia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Propionic Acidemia appearing as the primary indexed condition, and to 3 interventions - of which ornithine alpha ketoglutarate is the first listed.
NCT00645879 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT00645879 about?
NCT00645879 is a clinical study titled "Anaplerotic Therapy in Propionic Acidemia". The objective of this project is to define whether nutritional supplements (ornithine alpha-ketoglutarate, glutamine, or citrate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve hyperammonemia, glutamine levels, and outcome in patients with propionic acidemia. Ornithine...
What is the current status of trial NCT00645879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2008-07. Estimated completion is 2010-02.
What conditions does trial NCT00645879 study?
This clinical trial studies the following conditions: Propionic Acidemia.
What interventions are being tested in trial NCT00645879?
The interventions under investigation include: ornithine alpha ketoglutarate (DRUG), glutamine (DRUG), disodium citrate (DRUG).
Who is sponsoring clinical trial NCT00645879?
This trial is sponsored by Nicola Longo, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00645879 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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