Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT00031161
Eligibility Criteria:
Inclusion criteria:
* 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).
Exclusion criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
21 Years
Study:
NCT00031161
Study Brief:
Protocol Section:
NCT00031161