Ketogenic Diet for Child Epilepsy and Seizure Control - Full Text View

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT00004729

Purpose

Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even when treated with currently available anticonvulsant medications. Children with Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures. Preliminary data suggest that even when other medications have failed, these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency, medication toxicity, and improves quality of life.

Condition	Intervention
Epilepsy Seizures Lennox-Gastaut Syndrome	Behavioral: Ketogenic diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy of the Ketogenic Diet -- a Blinded Study

Resource links provided by NLM:

Genetics Home Reference related topics: Lennox-Gastaut syndrome pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Study Start Date:

July 1997

Detailed Description:

The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with "drop" seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

>15 myoclonic or atonic seizures a day
EEG with Lennox-Gastaut pattern

Exclusion Criteria:

<15 atonic or myoclonic seizures a day
on >3 medications
previously on diet and/or evidence of metabolic disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004729

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

John M. Freeman

Johns Hopkins University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004729 History of Changes
Other Study ID Numbers:	R01NS35980
Study First Received:	February 25, 2000
Last Updated:	December 21, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):

child
children
epilepsy
seizure

ketogenic
diet
Lennox-Gastaut Syndrome
LGS

Additional relevant MeSH terms:

Epilepsy
Seizures
Mental Retardation
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurologic Manifestations
Signs and Symptoms
Neurobehavioral Manifestations
Mental Disorders Diagnosed in Childhood
Mental Disorders
Epilepsy, Generalized

ClinicalTrials.gov processed this record on February 12, 2012