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Ketogenic Diet for Child Epilepsy and Seizure Control

Efficacy of the Ketogenic Diet -- a Blinded Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004729
Enrollment
Unknown
Registered
2000-02-28
Start date
1997-07-31
Completion date
Unknown
Last updated
2006-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Lennox-Gastaut Syndrome, Seizures

Keywords

child, children, epilepsy, seizure, ketogenic, diet, Lennox-Gastaut Syndrome, LGS

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.

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.

Interventions

BEHAVIORALKetogenic diet

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026