Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
ConditionSeizures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 50
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Ketogenic Therapy
Dietary supplementKetogenic 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.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Ketogenic TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reduced seizures
Seizures will be charted from collected data.
Time frame
2 yearsSecondary outcomes
1
Reduced requirement for medications
Medication will be charted from collected data.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov