Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
2 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
July 11, 2025
July 1, 2025
24.1 years
August 12, 2014
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduced seizures
Seizures will be charted from collected data.
2 years
Secondary Outcomes (1)
Reduced requirement for medications
2 years
Study Arms (1)
Ketogenic Therapy
EXPERIMENTALKetogenic Therapy will be administered.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peggy R. Borum, Ph.D.
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 15, 2014
Study Start
September 1, 2006
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2031
Last Updated
July 11, 2025
Record last verified: 2025-07