CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 3 enrolled
Drug / intervention
ornithine alpha ketoglutarate +2 moredrug
Likely dose
ornithine alpha ketoglutarate 400 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00645879
NCT00645879Phase 1Completed
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Safety & Efficacy of Investigational Products: Ornithine Alpha-ketoglutarate, Glutamine, or Disodium Citrate on Hyperammonemia in Propionic Acidemia.

Nicola Longo·interventional·Posted Mar 28, 2008·Updated Jan 21, 2015

In Brief

A Phase 1 clinical trial evaluating ornithine alpha ketoglutarate, glutamine, and 1 other intervention for Propionic Acidemia. Completed, enrolled 3 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPropionic Acidemia
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2008
Enrollment StartJul 1, 2008
Primary CompletionAug 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

ornithine alpha ketoglutaratedrug

A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effect, drug will be taken for 30 weeks.

glutaminedrug

A dose of 400 mg/kg up to 16 g per day was selected. Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.

disodium citratedrug

Dose: 7.5 mEq/Kg or 658 mg/kg up to 16 g per day Split into 2 doses taken for 4 weeks. If determined the drug with the best effects, drug will be taken for 30 weeks.