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

This study has been completed.

First Received: November 28, 2007 No Changes Posted

Sponsor:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00564915

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Dietary Supplement: Ketogenic diet	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Single Group Assignment
Official Title:	RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Diets Epilepsy

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	145
Study Start Date:	December 2001
Study Completion Date:	July 2006

Intervention Details:

Ketogenic diet

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564915

Locations

United Kingdom
Institute of Child Health, The Wolfson Centre
London, United Kingdom, WC1N 1EH

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:

Helen Cross, Professor

UCL Institute of Child Health

More Information

No publications provided

Responsible Party:	Institute of Child Health ( Tracy Assari )
Study ID Numbers:	98NR04
Study First Received:	November 28, 2007
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00564915 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:

Epilepsy

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 20, 2009