Ketogenic Diet for Child Epilepsy and Seizure Control

Efficacy of the Ketogenic Diet -- a Blinded Study

Patrocinadores

Patrocinador principal: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente National Institute of Neurological Disorders and Stroke (NINDS)
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio July 1997
Fase N/A
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Ketogenic diet

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 1 Year

Edad máxima: 10 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
John M. Freeman Principal Investigator Johns Hopkins University
Ubicación
Instalaciones: Johns Hopkins Hospital
Ubicacion Paises

United States

Fecha de verificación

December 2006

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov