SeizuresNCT02216500
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
A study testing Ketogenic Therapy in people with Seizures, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Seizures
- What is being tested?
- Ketogenic Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
About this study
Official title: Precision 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.
Read the detailed description
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.
- Conditions
- Seizures
- Being tested
- Ketogenic Therapy
- Keywords
- Ketogenic Therapy, Ketogenic Diet
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic TherapyDietary supplement
Also called Ketogenic Diet
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Therapy | Experimental | Ketogenic Therapy will be administered. Receives: Dietary Supplement: Ketogenic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced seizures
Seizures will be charted from collected data.
Measured: 2 years
Secondary outcomes (1)
Reduced requirement for medications
Medication will be charted from collected data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2006
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy R. Borum, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216500
- Sponsor's protocol ID
- IRB201500942
- Other IDs
- OCR25124
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2014
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No