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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 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.

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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

FieldValue
Enrollment Target 3 participants
Start Date 2008-07
Est. Completion 2010-02
Phase Phase 1

Sponsor

Nicola Longo

1 total trials

What the Registry Record Tells You About NCT00645879

The ClinicalTrials.gov registry entry for NCT00645879 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 225-participant average among 6 other Propionic Acidemia trials with a reported enrollment target (99% lower). The listed sponsor is Nicola Longo, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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