<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/NCT03014752</url>
  </required_header>
  <id_info>
    <org_study_id>9311468002</org_study_id>
    <nct_id>NCT03014752</nct_id>
  </id_info>
  <brief_title>Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy</brief_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>
      Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the&#xD;
      primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and&#xD;
      other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a&#xD;
      low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to&#xD;
      compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins&#xD;
      diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients&#xD;
      in each group, and will receive the diet for three months on non-randomised basis. In the&#xD;
      classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each&#xD;
      gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be&#xD;
      established on outpatient setting, without fasting and gradually. The modified Atkins diet&#xD;
      will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of&#xD;
      carbohydrate plus protein.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet</measure>
    <time_frame>Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the nutritional status of children and adolescents on the classical KD and MAD</measure>
    <time_frame>Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the lipid profiles of children and adolescents on the classical KD and MAD</measure>
    <time_frame>Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD</measure>
    <time_frame>Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Epilepsy Intractable</condition>
  <arm_group>
    <arm_group_label>Classical ketogenic diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Atkins diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classical ketogenic diet</intervention_name>
    <description>The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.</description>
    <arm_group_label>Classical ketogenic diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified Atkins diet</intervention_name>
    <description>The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.</description>
    <arm_group_label>Modified Atkins diet</arm_group_label>
    <other_name>MAD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents age 1 to 18 years Have not responded well to at least two&#xD;
             primary and one secondary antiepileptic drugs Have not received ketogenic diet therapy&#xD;
             previously Absence of renal diseases history Absence of cardiovascular diseases&#xD;
             history Absence of thyroid function disorders history Absence of cholesterol level&#xD;
             more than 300 mg/dl and Triglyceride level more than 200 mg/dl Absence of inherited&#xD;
             metabolic disorders that are contraindicated for ketogenic diet therapy including&#xD;
             fatty acid oxidation disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Onset of complications that threat the life of the patient Inability to continue the&#xD;
             diet Unwillingness to adhere the diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Childrens' Medical Center, Tehran University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <zip>1419733151</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>No</sharing_ipd>
    <ipd_description>The IPD would not share with other researchers.</ipd_description>
  </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/NCT03014752
org study id: 9311468002
nct id: NCT03014752
lead sponsor: 
has dmc: Yes
Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the
      primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and
      other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a
      low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to
      compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins
      diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients
      in each group, and will receive the diet for three months on non-randomised basis. In the
      classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each
      gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be
      established on outpatient setting, without fasting and gradually. The modified Atkins diet
      will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of
      carbohydrate plus protein.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
time frame: Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet
measure: Comparison of the nutritional status of children and adolescents on the classical KD and MAD
time frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
measure: Comparison of the lipid profiles of children and adolescents on the classical KD and MAD
time frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
measure: Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD
time frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
arm group label: Classical ketogenic diet
arm group type: Active Comparator
description: The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced.
arm group label: Modified Atkins diet
arm group type: Active Comparator
description: The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
intervention type: Other
intervention name: Classical ketogenic diet
description: The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
arm group label: Classical ketogenic diet
intervention type: Other
intervention name: Modified Atkins diet
description: The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
arm group label: Modified Atkins diet
other name: MAD
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: No
ipd description: The IPD would not share with other researchers.