An interventional study of Ketogenic Therapy in Seizures, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 400 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Exclusion Criteria:
Ketogenic Therapy will be administered.
Dietary Supplement: 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.
Also known as: Ketogenic Diet
Reduced seizures
Seizures will be charted from collected data.
Time frame: 2 years
Reduced requirement for medications
Medication will be charted from collected data.
Time frame: 2 years
The record gives a start of Sep 2006, a primary completion of Oct 2030 and a completion of Oct 2031. It does not say whether these dates are actual or estimated.
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