RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 28, 2007

Last Updated Date

November 28, 2007

Start Date ^ICMJE

December 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Tolerability and assessment of ketosis and growth [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Official Title ^ICMJE

RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Brief Summary

A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Dietary Supplement: Ketogenic diet

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

145

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week

Gender

Both

Ages

2 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00564915

Responsible Party

Tracy Assari, Institute of Child Health

Study ID Numbers ^ICMJE

98NR04

Study Sponsor ^ICMJE

Institute of Child Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Helen Cross, Professor

UCL Institute of Child Health

Information Provided By

Institute of Child Health

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP