<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/NCT03031028</url>
  </required_header>
  <id_info>
    <org_study_id>94-03-161-30342</org_study_id>
    <nct_id>NCT03031028</nct_id>
  </id_info>
  <brief_title>Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.</brief_title>
  <official_title>The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,&#xD;
      and moderate protein) in treating epilepsy. Investigators enroll a group of eligible&#xD;
      epileptic children and adolescent who have been referred from epilepsy center to our clinic&#xD;
      and prescribe them ketogenic diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research will be done to observe efficacy, safety, and tolerability of the classic&#xD;
      ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in&#xD;
      children with and adolescents with intractable epilepsy.&#xD;
&#xD;
      30 children and adolescents with intractable epilepsy based on inclusion and exclusion&#xD;
      criteria have been enrolled in the study, Investigators prescribe them classic ketogenic&#xD;
      diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic&#xD;
      drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure&#xD;
      record diary that is filled out by family of the patients and will be compared with data that&#xD;
      will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3&#xD;
      months after start of the diet. Patients will be reviewed at 1, 3 months after start of the&#xD;
      diet at outpatient clinic. Intolerances and Complications will be documented at each clinic&#xD;
      visits and via telephone calling during clinic visits intervals to evaluate tolerability and&#xD;
      safety of the KD. For close monitoring of the complications along with blood tests and&#xD;
      urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3&#xD;
      months after start of the diet. Laboratory values will be assessed at baseline and 3 months&#xD;
      after start of the diet. Also, nutritional status and growth of children will be assessed at&#xD;
      baseline and 1, 3 months after start of diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>Phase 2</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>seizure rate</measure>
    <time_frame>3 months</time_frame>
    <description>The information will be obtained through seizure diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Before and after 1 and 3 months on the classical KD.</time_frame>
    <description>Height of the participants will be assessed by stadiometer and Unit for height is cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigating side effects</measure>
    <time_frame>After 3 months on the classical KD</time_frame>
    <description>Side effects will be obtained via parents' reports.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum Triglyceride</measure>
    <time_frame>Before and after 3 months on the classical KD</time_frame>
    <description>serum Triglyceride will be assessed. Units for serum TG, is mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Before and after 1 and 3 months on the classical KD.</time_frame>
    <description>Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum Cholesterol,</measure>
    <time_frame>Before and after 3 months on the classical KD</time_frame>
    <description>serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum LDL-Cholesterol</measure>
    <time_frame>Before and after 3 months on the classical KD.</time_frame>
    <description>serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum HDL-Cholesterol</measure>
    <time_frame>Before and after 3 months on the classical KD</time_frame>
    <description>serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Refractory Epilepsy</condition>
  <arm_group>
    <arm_group_label>ketogenic diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ketogenic diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ketogenic diet</intervention_name>
    <description>Ketogenic Diet is a high fat, low carbohydrate diet.</description>
    <arm_group_label>ketogenic diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 1-18 years,&#xD;
&#xD;
          -  The patient has tried at least 3 different AED:s including one combination with two or&#xD;
             more different AED:s.&#xD;
&#xD;
          -  The parents are willing to include their child in the study after written and verbal&#xD;
             information.&#xD;
&#xD;
          -  Patients with all types of epilepsy can be included.&#xD;
&#xD;
          -  The patient is submitted to our epilepsy center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has a medical condition, for example a metabolic disease, where ketogenic&#xD;
             diet is contraindicated.&#xD;
&#xD;
          -  The patient's nutritional status is not good enough or intake of fluid is to small to&#xD;
             permit treatment with ketogenic diet.&#xD;
&#xD;
          -  No history of hyperlipidemia&#xD;
&#xD;
          -  No history of renal stones&#xD;
&#xD;
          -  No previous treatment with ketogenic diet&#xD;
&#xD;
          -  Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain&#xD;
             acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency&#xD;
             (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3-&#xD;
             hydroxyacyl-CoA deficiency.&#xD;
&#xD;
          -  The family is expected to have compliance problems with treatment and/or seizure&#xD;
             registration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maryam Mahmoudi, MD, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Tehran university of medical science, school of Nutritional science and Dietetics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maryam Mahmoudi, MD, PHD</last_name>
    <phone>00989126182883</phone>
    <email>m-mahmoudi@sina.tums.ac.ir</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mona Kavoosi, MSc student</last_name>
    <phone>00989123759711</phone>
    <email>m_kavoosi@razi.tums.ac.ir</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tehran university of medical science, school of nutritional science and dietetics</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maryam Mahmoudi, MD,PHD</last_name>
      <phone>00989126182883</phone>
      <email>m-mahmoudi@sina.tums.ac.ir</email>
    </contact>
    <investigator>
      <last_name>Mona Kavoosi, MSc student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>refractory epilepsy,</keyword>
  <keyword>ketogenic diet</keyword>
  <keyword>classic ketogenic diet</keyword>
  <keyword>seizure rate</keyword>
  <keyword>efficacy</keyword>
  <keyword>epilepsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031028
org study id: 94-03-161-30342
nct id: NCT03031028
lead sponsor: 
has dmc: Yes
This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate,
      and moderate protein) in treating epilepsy. Investigators enroll a group of eligible
      epileptic children and adolescent who have been referred from epilepsy center to our clinic
      and prescribe them ketogenic diet.
This research will be done to observe efficacy, safety, and tolerability of the classic
      ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in
      children with and adolescents with intractable epilepsy.

      30 children and adolescents with intractable epilepsy based on inclusion and exclusion
      criteria have been enrolled in the study, Investigators prescribe them classic ketogenic
      diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic
      drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure
      record diary that is filled out by family of the patients and will be compared with data that
      will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3
      months after start of the diet. Patients will be reviewed at 1, 3 months after start of the
      diet at outpatient clinic. Intolerances and Complications will be documented at each clinic
      visits and via telephone calling during clinic visits intervals to evaluate tolerability and
      safety of the KD. For close monitoring of the complications along with blood tests and
      urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3
      months after start of the diet. Laboratory values will be assessed at baseline and 3 months
      after start of the diet. Also, nutritional status and growth of children will be assessed at
      baseline and 1, 3 months after start of diet.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: seizure rate
time frame: 3 months
description: The information will be obtained through seizure diary
measure: Height
time frame: Before and after 1 and 3 months on the classical KD.
description: Height of the participants will be assessed by stadiometer and Unit for height is cm.
measure: Investigating side effects
time frame: After 3 months on the classical KD
description: Side effects will be obtained via parents' reports.
measure: serum Triglyceride
time frame: Before and after 3 months on the classical KD
description: serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
measure: Weight
time frame: Before and after 1 and 3 months on the classical KD.
description: Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.
measure: serum Cholesterol,
time frame: Before and after 3 months on the classical KD
description: serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.
measure: serum LDL-Cholesterol
time frame: Before and after 3 months on the classical KD.
description: serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.
measure: serum HDL-Cholesterol
time frame: Before and after 3 months on the classical KD
description: serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL
arm group label: ketogenic diet
arm group type: Other
description: Ketogenic diet
intervention type: Other
intervention name: ketogenic diet
description: Ketogenic Diet is a high fat, low carbohydrate diet.
arm group label: ketogenic diet
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Maryam Mahmoudi, MD, PHD
role: Study Director
affiliation: Tehran university of medical science, school of Nutritional science and Dietetics
last name: Maryam Mahmoudi, MD, PHD
phone: 00989126182883
email: m-mahmoudi@sina.tums.ac.ir
last name: Mona Kavoosi, MSc student
phone: 00989123759711
email: m_kavoosi@razi.tums.ac.ir
facility: 
status: Recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: Undecided