Effects of a Ketogenic Diet on Seizures in Children
Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
NA · University of Florida · NCT02216500
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | N/A to 50 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT02216500 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children whose physicians have prescribed the ketogenic diet and who can metabolize a high-fat, low-carbohydrate diet.
Not a fit: Patients with metabolic issues that prevent them from safely following a high-fat diet may not benefit from this study.
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 performed: Previous studies have shown promising results with ketogenic therapy for epilepsy, indicating that this approach is both established and potentially effective.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Seizures, Ketogenic Therapy, Ketogenic Diet