Congenital Lactic Acidosis Clinical Trial
Official title:
Pharmacotoxicology of Trichloroethylene Metabolites
To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.
The arms of the study involves determining the haplotype of individuals enrolled. Then
participants were divided into two groups based on their genotype. The groups include a
genotype with an EGT alle and a group of genotype without an EGT alle. All subjects first
took a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of
DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics were be
done. A total of 16 blood samples were obtained through an intravenous catheter. Urine
collection will also occur.
Population pharmacogenetic analysis of MAI allelic frequencies and the GC or LC-MS/MS
techniques for blood or urinary metabolites were used in this investigation. Pharmacokinetic
data was used to determine metabolism rate of DCA for each allele
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label