Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy



Status:Recruiting
Conditions:Neurology, Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:Any - 50
Updated:10/20/2018
Start Date:September 2006
End Date:October 2020
Contact:Peggy R. Borum, Ph.D.
Email:prb@ufl.edu
Phone:352-562-2861

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials