Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

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

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2031-10-31

Brief Summary

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Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. This natural history study will collect data pertaining to both questions.

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Detailed Description

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The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the brain. Induction of ketosis has been shown to correlate with the reduction of seizures observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. The investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and requirements for antiepileptic drugs. The investigators will evaluate adverse effects of Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal daily administration of therapy with structured training programs for caregivers.

Conditions

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Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketogenic Therapy

Ketogenic Therapy will be administered.

Group Type EXPERIMENTAL

Ketogenic Therapy

Intervention Type DIETARY_SUPPLEMENT

Ketogenic Therapy is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate, fat intake is high, and carbohydrate intake is minimal.

Interventions

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Ketogenic Therapy

Ketogenic Therapy is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate, fat intake is high, and carbohydrate intake is minimal.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ketogenic Diet

Eligibility Criteria

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Inclusion Criteria

* Patients whose physician has prescribed the ketogenic diet
* Patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet
* Patients that can be compliant with administration of the therapy and with record keeping.

Exclusion Criteria

* Patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet
* Patients at risk of being non-compliant with administration of the therapy and with record keeping

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No