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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 17, 2001 |
| Last Updated Date | September 1, 2006 |
| Start Date ICMJE | December 1994 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00015015 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Dichloroacetate Kinetics, Metabolism and Toxicology |
| Official Title ICMJE | |
| Brief 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. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Screening, Longitudinal, Defined Population, Prospective Study |
| Condition ICMJE | Lactic Acidosis |
| Intervention ICMJE | Drug: Dichloroacetate |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 100 |
| Completion Date | October 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Children with congenital lactic acidosis Healthy adult volunteers |
| Gender | Both |
| Ages | 3 Months to 65 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00015015 |
| Responsible Party | |
| Study ID Numbers ICMJE | 7355-CP-001 |
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) |
| Verification Date | September 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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