Ketogenic Diet for Child Epilepsy and Seizure Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy Seizures Lennox-Gastaut Syndrome

Keywords

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child children epilepsy seizure ketogenic diet Lennox-Gastaut Syndrome LGS

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ketogenic diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John M. Freeman

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01NS035980

Identifier Type: NIH

Identifier Source: org_study_id

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