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Ketogenic Diet for Child Epilepsy and Seizure Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004729
Recruitment Status : Completed
First Posted : February 28, 2000
Last Update Posted : December 22, 2006
Sponsor:
Information provided by:

February 25, 2000
February 28, 2000
December 22, 2006
July 1997
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Complete list of historical versions of study NCT00004729 on ClinicalTrials.gov Archive Site
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Ketogenic Diet for Child Epilepsy and Seizure Control
Efficacy of the Ketogenic Diet -- a Blinded Study
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.
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.
Interventional
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Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Epilepsy
  • Seizures
  • Lennox-Gastaut Syndrome
Behavioral: Ketogenic diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
1 Year to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004729
R01NS035980( U.S. NIH Grant/Contract )
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: John M. Freeman Johns Hopkins University
National Institute of Neurological Disorders and Stroke (NINDS)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP