Prevention of Dichloroacetate Toxicity
Completed · Not applicable
Conditions studied: Acidosis, Lactic, Chronic Disease
In brief
This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).
Key facts
- Study ID
- NCT00031161
- Run by
- University of Florida
- People needed
- 30
- Starts
- 2001-09-01
- Expected to finish
- 2005-09-01
- Last updated by the study team
- 2015-03-25
Who can join
Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Biochemical or molecular genetic proof of a defect in mitochondrial enzyme of glucose metabolism or oxidative phosphorylation.
- Clinical history consistent with CLA (e.g., basal hyperlactatemia, stroke-like episodes, neuromuscular degeneration, and seizures).
- Ability to withstand an 8-hour fast (if 2 years old or younger) or a 12-hour fast without developing hypoglycemia (blood glucose greater than or equal to 50 mg/dL).
You may not qualify if…
- Secondary lactic acidosis due to impaired oxygenation or circulation.
- Hyperlactatemia associated with proven biotinidase deficiency or with enzyme deficiencies of gluconeogenesis.
- Primary, defined organic acidurias other than lactic acidosis for which effective therapy is available (e.g., propionic aciduria).
- Primary disorders of amino acid metabolism.
- Primary disorders of fatty acid oxidation.
- Malabsorption syndromes associated with D-lactic acidosis.
- Renal insufficiency.
- Serum creatinine greater than 1.2 mg/g.
- Creatinine clearance less than or equal to 60 mL/min.
- Primary hepatic disease unrelated to chronic lactic acidosis.
- In patients with pyruvate dehydrogenase enzyme complex deficiency, an inability to maintain a diet greater than 50% calories from fat without biological and/or neurological deterioration.
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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