Dichloroacetate Kinetics, Metabolism and Toxicology | NCT00015015

Studies
Dichloroacetate Kinetics, Metabolism and Toxicology

NCT00015015

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Status

Completed

Last Update Posted

Sep 4, 2006Estimated

Enrollment

100

Phase

Not provided

Conditions

Lactic Acidosis

Interventions

Dichloroacetate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1994

Primary Completion Date

Not provided

Completion Date

Oct 2002

First Submitted Date

Apr 17, 2001

First Submission Date that Met QC Criteria

Apr 18, 2001

First Posted Date

Apr 19, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2006

Last Update Posted Date

Sep 4, 2006Estimated

Description Module

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Dichloroacetate	Drug

Eligibility Module

Eligibility Criteria

Children with congenital lactic acidosis Healthy adult volunteers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univ. of Florida		Gainesville	Florida	32610	United States

Condition Browse Module

MeSH Terms

ID	Term
D000140	Acidosis, Lactic
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003999	Dichloroacetic Acid

Ancestor Terms

ID	Term
D062845	Chloroacetates
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided