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Ketogenic Diet for Child Epilepsy and Seizure Control

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ClinicalTrials.gov Identifier: NCT00004729
Recruitment Status : Completed
First Posted : February 28, 2000
Last Update Posted : December 22, 2006
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Seizures Lennox-Gastaut Syndrome Behavioral: Ketogenic diet Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of the Ketogenic Diet -- a Blinded Study
Study Start Date : July 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00004729     History of Changes
Other Study ID Numbers: R01NS035980 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2000    Key Record Dates
Last Update Posted: December 22, 2006
Last Verified: December 2006

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