NCT02216500 · University of Florida
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Reduced seizures
Time frame: 2 years
Seizures will be charted from collected data.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations