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NCT00015015 Clinical Trial

Dichloroacetate Kinetics, Metabolism and Toxicology

Lactic Acidosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00015015
Other study ID # 7355-CP-001
Secondary ID
Status Completed
Phase N/A
First received April 17, 2001
Last updated September 1, 2006
Start date December 1994
Est. completion date October 2002

Study information
Verified date September 2006
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain industrial solvents, thus making it a chemical of environmental concern. However, DCA is also used as an investigational drug for treating various diseases of adults and children, at doses far greater than those to which humans are normally exposed in the environment. Our research involves how DCA is metabolized by healthy adults and by children with a fatal genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 65 Years
Eligibility Children with congenital lactic acidosis Healthy adult volunteers

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• Dichloroacetate

Locations
Country Name City State
United States Univ. of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

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