<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216500</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201500942</org_study_id>
    <secondary_id>OCR25124</secondary_id>
    <nct_id>NCT02216500</nct_id>
  </id_info>
  <brief_title>Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy</brief_title>
  <official_title>Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately a fourth of children with seizures do not respond adequately to available&#xD;
      therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but&#xD;
      there is no agreement concerning how it works and what is the best way to administer it. This&#xD;
      natural history study will collect data pertaining to both questions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of&#xD;
      fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On&#xD;
      Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the&#xD;
      brain. Induction of ketosis has been shown to correlate with the reduction of seizures&#xD;
      observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that&#xD;
      the compounds provided to stop seizure activity are the same compounds provided for growth&#xD;
      and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is&#xD;
      also a potential risk factor for dyslipidemia and may adversely affect growth. The&#xD;
      investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and&#xD;
      requirements for antiepileptic drugs. The investigators will evaluate adverse effects of&#xD;
      Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal&#xD;
      daily administration of therapy with structured training programs for caregivers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduced seizures</measure>
    <time_frame>2 years</time_frame>
    <description>Seizures will be charted from collected data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduced requirement for medications</measure>
    <time_frame>2 years</time_frame>
    <description>Medication will be charted from collected data.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Seizures</condition>
  <arm_group>
    <arm_group_label>Ketogenic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ketogenic Therapy will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ketogenic Therapy</intervention_name>
    <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.</description>
    <arm_group_label>Ketogenic Therapy</arm_group_label>
    <other_name>Ketogenic Diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose physician has prescribed the ketogenic diet&#xD;
&#xD;
          -  Patients with lab tests consistent with the ability to metabolize a high fat and low&#xD;
             carbohydrate diet&#xD;
&#xD;
          -  Patients that can be compliant with administration of the therapy and with record&#xD;
             keeping.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with lab tests consistent with the inability to metabolize a high fat and low&#xD;
             carbohydrate diet&#xD;
&#xD;
          -  Patients at risk of being non-compliant with administration of the therapy and with&#xD;
             record keeping&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peggy R. Borum, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peggy R. Borum, Ph.D.</last_name>
    <phone>352-562-2861</phone>
    <email>prb@ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ketogenic Therapy</keyword>
  <keyword>Ketogenic Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216500
org study id: IRB201500942
secondary id: OCR25124
nct id: NCT02216500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduced seizures
time frame: 2 years
description: Seizures will be charted from collected data.
measure: Reduced requirement for medications
time frame: 2 years
description: Medication will be charted from collected data.
arm group label: Ketogenic Therapy
arm group type: Experimental
description: Ketogenic Therapy will be administered.
intervention type: Dietary Supplement
intervention name: Ketogenic Therapy
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.
arm group label: Ketogenic Therapy
other name: Ketogenic Diet
criteria: 
gender: All
minimum age: N/A
maximum age: 50 Years
healthy volunteers: No
last name: Peggy R. Borum, Ph.D.
role: Principal Investigator
affiliation: University of Florida
last name: Peggy R. Borum, Ph.D.
phone: 352-562-2861
email: prb@ufl.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Seizures