Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Primary Purpose
Seizures
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring Ketogenic Therapy, Ketogenic Diet
Eligibility 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
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketogenic Therapy
Arm Description
Ketogenic Therapy will be administered.
Outcomes
Primary Outcome Measures
Reduced seizures
Seizures will be charted from collected data.
Secondary Outcome Measures
Reduced requirement for medications
Medication will be charted from collected data.
Full Information
NCT ID
NCT02216500
First Posted
August 12, 2014
Last Updated
December 19, 2022
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT02216500
Brief Title
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Official Title
Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
Ketogenic Therapy, Ketogenic Diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic Therapy
Arm Type
Experimental
Arm Description
Ketogenic Therapy will be administered.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic Therapy
Other Intervention Name(s)
Ketogenic Diet
Intervention Description
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 Information:
Title
Reduced seizures
Description
Seizures will be charted from collected data.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Reduced requirement for medications
Description
Medication will be charted from collected data.
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy R. Borum, Ph.D.
Phone
352-562-2861
Email
prb@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy R. Borum, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
We'll reach out to this number within 24 hrs