Ketogenic Diet for Child Epilepsy and Seizure Control

This study has been completed.

Sponsor:

Information provided by:

National Institute of Neurological Disorders and Stroke (NINDS)

ClinicalTrials.gov Identifier:

NCT00004729

First received: February 25, 2000

Last updated: December 21, 2006

Last verified: December 2006

History of Changes

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

MedlinePlus related topics: Epilepsy Seizures

Genetic and Rare Diseases Information Center resources: Lennox-Gastaut Syndrome

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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00004729 History of Changes
Other Study ID Numbers:	R01NS035980
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 Lennox Gastaut Syndrome Brain Diseases Central Nervous System Diseases	Nervous System Diseases Neurologic Manifestations Signs and Symptoms Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 28, 2016

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