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NCT Number: NCT02216500

Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

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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Key information

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic Therapy

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.

Other names: Ketogenic Diet

Primary outcomes

  1. Reduced seizures

    Time frame: 2 years

    Seizures will be charted from collected data.

Secondary outcomes

  1. Reduced requirement for medications

    Time frame: 2 years

    Medication will be charted from collected data.

Study contacts

Contact information is provided by the study sponsor or research team.

Peggy R. Borum, Ph.D.

CONTACT

[email protected]

352-562-2861

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

Important dates

Study start
2006
Primary completion
2030
Study completion
2031
First posted
Aug 15, 2014
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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