Clinical Trials Directory

Trials / Completed

CompletedNCT00004729

Ketogenic Diet for Child Epilepsy and Seizure Control

Efficacy of the Ketogenic Diet -- a Blinded Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · NIH
Sex
All
Age
1 Year – 10 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALKetogenic diet

Timeline

Start date
1997-07-01
First posted
2000-02-28
Last updated
2006-12-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004729. Inclusion in this directory is not an endorsement.