NCT00015015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

April 17, 2001

Last Update Submit

September 1, 2006

Conditions

Lactic Acidosis

Keywords

DichloroacetateChlorinated hydrocarbonsGenetic diseaseToxicologyBiotransformation

Interventions

DichloroacetateDRUG

Eligibility Criteria

Age3 Months - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Children with congenital lactic acidosis Healthy adult volunteers

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Univ. of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Acidosis, LacticGenetic Diseases, Inborn

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 17, 2001

First Posted

April 19, 2001

Study Start

December 1, 1994

Study Completion

October 1, 2002

Last Updated

September 4, 2006

Record last verified: 2006-09

Locations

US(1)