Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

Not Applicable

Recruiting

• Conditions: Seizures
• Interventions: Dietary Supplement: Ketogenic Therapy

• Registration Number: NCT02216500
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2030-10
• Study Completion: 2031-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic Therapy	Ketogenic Therapy	Ketogenic Therapy will be administered.

Primary Outcome Measures

Name	Time	Method
Reduced seizures	2 years	Seizures will be charted from collected data.

Secondary Outcome Measures

Name	Time	Method
Reduced requirement for medications	2 years	Medication will be charted from collected data.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States