Effects of a Ketogenic Diet on Seizures in Children
Official title: Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Run by University of Florida · NCT02216500 · Data updated 2026-11-12
This study tests if a ketogenic diet can help children with seizures who don't respond well to regular treatments by looking at how it affects their seizure frequency and medication needs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 50 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | September 2006 |
| Main results expected | October 2030 |
| Study ends | October 2031 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT02216500 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children whose physicians have prescribed the ketogenic diet and who can metabolize a high-fat, low-carbohydrate diet.
✕Probably not a fit
Patients with metabolic issues that prevent them from safely following a high-fat diet may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of ketogenic therapy on children with seizures who do not respond adequately to standard treatments. It focuses on understanding how the ketogenic diet, which alters macronutrient intake to favor fats over carbohydrates, impacts seizure frequency and the need for antiepileptic medications. The study will also assess potential adverse effects, such as dyslipidemia and growth issues, while providing structured training for caregivers to ensure proper administration of the therapy. Data collected will help clarify the efficacy and safety of this treatment approach.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children with intractable epilepsy.
How similar studies have gone: Previous studies have shown promising results with ketogenic therapy for epilepsy, indicating that this approach is both established and potentially effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Peggy R. Borum, Ph.D. — University of Florida
- Study coordinator: Peggy R. Borum, Ph.D.
- Email: prb@ufl.edu
- Phone: 352-562-2861
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.