ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Ketogenic Diet for Child Epilepsy and Seizure Control

This study has been completed.

Sponsored by: 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

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

MedlinePlus related topics:   Epilepsy    Seizures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control
Official Title:   Efficacy of the Ketogenic Diet -- a Blinded Study

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

Investigators
Principal Investigator:     John M. Freeman     Johns Hopkins University    
  More Information

Study ID Numbers:   R01NS35980
First Received:   February 25, 2000
Last Updated:   December 21, 2006
ClinicalTrials.gov Identifier:   NCT00004729
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

Study placed in the following topic categories:
Signs and Symptoms
Epilepsy
Epileptic encephalopathy, Lennox-Gastaut type
Seizures
Cutis verticis gyrata
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2008




Links to all studies - primarily for crawlers