Ketogenic Diet Program for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,
      and moderate protein) in treating epilepsy. Two study groups will be comprised of children
      with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet -
      epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.
    

Detailed description: 
      According to an evidence-based guideline on the diagnosis and management of epilepsy from the
      National Institute for Clinical Excellence (2012), the ketogenic diet may be considered as an
      adjunctive treatment in children with drug-resistant epilepsy. Vast anecdotal and Class 1
      studies have confirmed that the ketogenic diet helps most children with intractable seizures
      and cures many. Dietary therapies for epilepsy (e.g., classic ketogenic diet) have been shown
      to be highly effective. For example, Lee (P.R.) and Kossoff reported that approximately 50%
      of children with drug-resistant epilepsy had a greater than 50% reduction in seizures within
      days to months of treatment. In addition, use of the ketogenic diet as a treatment for
      epilepsy has been shown to reduce the escalating costs associated managing poorly controlled
      seizures (e.g., decrease in outpatient and emergency visits, inpatient hospitalization,
      neuroimaging, electro-encephalography, lab testing, and medication use).

      If a child's seizures continue after two to three seizure medications have been tried, the
      ketogenic diet should be considered. However, many parents still medicate their children well
      beyond these guidelines and tolerate seizure frequency because they have no other
      alternatives. Given the physical and emotional toll that recurring seizures exact upon these
      children/families, the potential for improvement with the ketogenic diet is substantial.
      However, the ketogenic diet remains unavailable to most children.

      Approximately 1% of Hawaii's children are projected to have epilepsy, but there is no
      established, ketogenic diet program for them to receive this dietary intervention, which can
      incorporate culturally distinct foods to improve palatability and compliance. Although the
      ketogenic diet has shown promise for broadening the scope of therapeutic options for children
      with epilepsy, it requires further study in an ethnically diverse population. At Shriners
      Hospitals for Children-Honolulu, the investigators have initiated a ketogenic and related
      dietary (e.g., modified Atkins diet) intervention program for children with epilepsy and
      started to assess its efficacy in treating epilepsy/seizures. This program also includes
      educational seminars and services to patients residing on the other Hawaii islands through
      outreach trips. The investigators have begun to enroll children with epilepsy into two groups
      based on whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and
      epilepsy/non-ketogenic diet; total estimate of 15-30 participants over three years. Based
      upon initial findings, the investigators will implement a comprehensive, multidisciplinary
      ketogenic diet program that will potentially reach hundreds of children throughout Hawaii,
      the Pacific Basin, and elsewhere.

      Specific Aims:

      Aim 1. To assess the therapeutic efficacy of the ketogenic diet on epilepsy/seizures.

      Hypothesis: Participants who have epilepsy/on the ketogenic diet will have significantly
      decreased number and severity of seizures than those that are not on the ketogenic diet,
      between baseline to three and six months after the dietary intervention is initiated.

      Aim 2. In anticipation of lessened epilepsy/seizures, to determine the (a) change in number
      and dose of seizure medications used, (b) change in number of lab tests ordered for epilepsy
      management, (c) change in number of emergency room and hospital visits for seizures (or other
      neurodevelopmental problems), (d) change in number of neurologic procedures for epilepsy
      management (e.g. EEG, MRI, CT), and (e) participant/family satisfaction with the ketogenic
      diet.

      Hypothesis: The number and/or dosage of medications, lab tests ordered, emergency room or
      hospital visits, and neurologic procedures for epilepsy management will decrease, and
      participant/family satisfaction will be high for participants who have epilepsy/on the
      ketogenic diet than those that are not on the ketogenic diet, between baseline to three and
      six months after the dietary intervention is initiated.

      Aim 3. To compare differences and/or changes in (a) serum and urine ketone levels and (b)
      biochemical profiles as defined from blood and stool (gut or fecal microbiome) specimen
      samples.

      Hypothesis: Participants who have epilepsy/on the ketogenic diet will have significantly
      higher serum/urine ketone levels and notably different biochemical profiles than those that
      are not on the ketogenic diet, between baseline to three and six months after the dietary
      intervention is initiated.

      Children helped by the ketogenic diet are more likely to reach their highest level of
      functioning and become contributing adults. By providing the ketogenic diet as an
      intervention therapy for epilepsy in a safe and data-driven manner, the community-at-large
      will benefit and medical knowledge concerning dietary treatment for neurodevelopmental
      disorders will be advanced.
    

Intervention name(s): Ketogenic Diet
Intervention type(s): Other
Intervention description(s): Dietary
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Intractable Seizures; Ketogenic Diet; Biochemical Profiles