Recruiting

Ketogenic Therapy

Sponsor:

University of Florida

Code:

NCT02216500

Conditions

Seizures

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Interventions

Ketogenic Therapy

Study Details

Brief 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. This natural history study will collect data pertaining to both questions.

Conditions

Seizures

Study ID

NCT02216500

Start date

Sep, 2006

Status verified date

Sep, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketogenic Therapy

Ketogenic Therapy will be administered.

Interventions

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 measure

  • Reduced seizures [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Peggy R. Borum, Ph.D.

352-562-2861prb@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

More Information

Sponsor

University of Florida

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • Ketogenic Therapy
  • Ketogenic Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Florida on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.