Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic Therapy.
- Who it may be relevant to
- Registry conditions: Seizures. Basic parameters: up to 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Overview
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.
Interventions
- Dietary supplement 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 measures
- Reduced seizures [Time frame: 2 years]
Secondary outcome measures (1)
- Reduced requirement for medications [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT02216500 · IRB201500942 · OCR25124