<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/NCT03764956</url>
  </required_header>
  <id_info>
    <org_study_id>IECPG/504/10/2018</org_study_id>
    <nct_id>NCT03764956</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy</brief_title>
  <official_title>Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</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>
      To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for&#xD;
      treatment of drug resistant epilepsy in children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current&#xD;
      treatment options for DRE include epileptic surgery and dietary therapy. Classic KD&#xD;
      (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and&#xD;
      practical difficulty makes it difficult to follow. So less restrictive diets like MAD and&#xD;
      LGIT were introduced. These are reported to have less adverse effects also. But no published&#xD;
      study has ever been conducted comparing these two diets head to head.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open label randomized non inferiority trial with two parallel arms</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of seizure reduction from baseline at 24 weeks of therapy</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of children who achieve &gt;50% seizure reduction</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Number of children with &gt;50% reduction divided by number of children in each arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Routine hemogram, Renal function test (RFT), Liver function test (LFT) and lipid profile will be assessed for any alterations. Adverse events, vomiting, constipation and diarrhea will be checked by parents record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Weekly compliance assessment of each participant will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social quotient(SQ) with each dietary therapies</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Proportion of children with improvement in Social quotient (SQ) assessed by Vineland Social Maturity Scale (VSMS) at 24 weeks. VSMS consists of 8 subsets - Communication skills, General self-help ability, Locomotion skills, Occupation skills, Self-direction, Self-help eating, Self-help dressing, Socialization skills. Social age is calculated by adding the scores of all subsets. Social quotient (SQ) is calculated by social age divided by chronological age multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>In children less than 4 years quality of life is assessed by PedsQL (Pediatric Quality of life inventory). PedsQL consists of 21 questions each having 5 responses with scores 0,1,2,3 and 4. Minimum score is 0 and maximum is 84. Quality of life is poor with larger score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>In children with age 4 years or more, QOLCE 55 (Quality of life in childhood epilepsy questionnaire) is used to assess quality of life. QOLCE 55 consists of 55 questions which are classified into 4 categories. Each question have 5 responses with scores as 0,25,50,75 and 100. Mean score of each category is calculated and final score calculated by mean of the scores of 4 categories. Minimum score is 0 and maximum is 100. Quality of life is better with larger score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life of caregivers at 24 weeks as compared to baseline</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Quality of life of caregivers is assessed by WHOQOL-BREF. WHOQOL BREF contains 26 items categorized into 4 domains. For each question response is scored 1,2,3,4 or 5. Total raw score is then calculated and is converted to transformed score. Minimum score is 0 and maximum is 100. Quality of life is poor with smaller score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota (GM) analysis pre and post dietary therapy</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in behavioral abnormalities with each dietary therapy</measure>
    <time_frame>At the end of 24 weeks of dietary therapy</time_frame>
    <description>Behavior assessment is done using Child behavior check list (CBCL).This questionnaire contains 100 and 113 questions for age groups of 1 ½ - 5 years and 6-18 years respectively. Score of 2 will be given for a response of 'very true', 1 for a response of 'somewhat true' and 0 for 'not true'. Total score is obtained by adding all the subsets. Subsets for age 1.5 years to 5 years include - Emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior and other problems. Subsets for age 6 years to 12 years include - Anxious/Depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, aggressive behavior, other problems. Raw score is then converted to T score according to the published charts. Minimum T score is 28 and maximum is 100. Larger score indicates more behavioral problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Drug Resistant Epilepsy</condition>
  <condition>Ketogenic Dieting</condition>
  <arm_group>
    <arm_group_label>Low Glycemic Index therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Atkins Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low glycemic Index Therapy (LGIT)</intervention_name>
    <description>Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.</description>
    <arm_group_label>Low Glycemic Index therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified Atkins Diet (MAD)</intervention_name>
    <description>Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.</description>
    <arm_group_label>Modified Atkins Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 1-15 years with drug resistant epilepsy&#xD;
&#xD;
          -  Willing to come for regular follow-up according to study protocol Drug resistant&#xD;
             epilepsy defined as&#xD;
&#xD;
          -  Seizure frequency &gt;4 seizures per month, while on optimal doses of at least 2&#xD;
             prescribed antiepileptic drugs&#xD;
&#xD;
          -  For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of&#xD;
             spasms per month despite treatment with antiepileptic drugs and either&#xD;
             ACTH(Adrenocorticotrophic hormone) or Vigabatrin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgically remediable causes for DRE&#xD;
&#xD;
          -  Inborn errors of metabolism&#xD;
&#xD;
          -  Previously received KD, MAD or LGIT&#xD;
&#xD;
          -  Known case of&#xD;
&#xD;
               1. Chronic kidney disease&#xD;
&#xD;
               2. Chronic liver disease/GI illness&#xD;
&#xD;
               3. Congenital/acquired heart disease&#xD;
&#xD;
               4. Chronic respiratory illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheffali Gulati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheffali Gulati, MD</last_name>
    <phone>9810386847</phone>
    <email>sheffaligulati@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vaishakh Anand, MD</last_name>
    <phone>7838528549</phone>
    <email>drvyshakhanandmp@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gulati Sheffali, MD</last_name>
      <phone>9868397532</phone>
      <email>sheffaligulati@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Gulati Sheffali, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AIIMS</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheffali Gulati, M.D.</last_name>
      <phone>26594679</phone>
      <phone_ext>011</phone_ext>
      <email>sheffaligulati@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Sheffali Gulati</investigator_full_name>
    <investigator_title>Professor, Chief, Child Neurology Division</investigator_title>
  </responsible_party>
  <keyword>MAD</keyword>
  <keyword>LGIT</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/NCT03764956
org study id: IECPG/504/10/2018
nct id: NCT03764956
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for
      treatment of drug resistant epilepsy in children
Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current
      treatment options for DRE include epileptic surgery and dietary therapy. Classic KD
      (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and
      practical difficulty makes it difficult to follow. So less restrictive diets like MAD and
      LGIT were introduced. These are reported to have less adverse effects also. But no published
      study has ever been conducted comparing these two diets head to head.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open label randomized non inferiority trial with two parallel arms
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of seizure reduction from baseline at 24 weeks of therapy
time frame: At the end of 24 weeks of dietary therapy
description: Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100
measure: Proportion of children who achieve >50% seizure reduction
time frame: At the end of 24 weeks of dietary therapy
description: Number of children with >50% reduction divided by number of children in each arm
measure: Incidence of adverse events
time frame: At the end of 24 weeks of dietary therapy
description: Routine hemogram, Renal function test (RFT), Liver function test (LFT) and lipid profile will be assessed for any alterations. Adverse events, vomiting, constipation and diarrhea will be checked by parents record
measure: Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
time frame: At the end of 24 weeks of dietary therapy
description: Weekly compliance assessment of each participant will be done
measure: Change in Social quotient(SQ) with each dietary therapies
time frame: At the end of 24 weeks of dietary therapy
description: Proportion of children with improvement in Social quotient (SQ) assessed by Vineland Social Maturity Scale (VSMS) at 24 weeks. VSMS consists of 8 subsets - Communication skills, General self-help ability, Locomotion skills, Occupation skills, Self-direction, Self-help eating, Self-help dressing, Socialization skills. Social age is calculated by adding the scores of all subsets. Social quotient (SQ) is calculated by social age divided by chronological age multiplied by 100.
measure: Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
time frame: At the end of 24 weeks of dietary therapy
description: In children less than 4 years quality of life is assessed by PedsQL (Pediatric Quality of life inventory). PedsQL consists of 21 questions each having 5 responses with scores 0,1,2,3 and 4. Minimum score is 0 and maximum is 84. Quality of life is poor with larger score.
measure: Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline
time frame: At the end of 24 weeks of dietary therapy
description: In children with age 4 years or more, QOLCE 55 (Quality of life in childhood epilepsy questionnaire) is used to assess quality of life. QOLCE 55 consists of 55 questions which are classified into 4 categories. Each question have 5 responses with scores as 0,25,50,75 and 100. Mean score of each category is calculated and final score calculated by mean of the scores of 4 categories. Minimum score is 0 and maximum is 100. Quality of life is better with larger score.
measure: Change in Quality of Life of caregivers at 24 weeks as compared to baseline
time frame: At the end of 24 weeks of dietary therapy
description: Quality of life of caregivers is assessed by WHOQOL-BREF. WHOQOL BREF contains 26 items categorized into 4 domains. For each question response is scored 1,2,3,4 or 5. Total raw score is then calculated and is converted to transformed score. Minimum score is 0 and maximum is 100. Quality of life is poor with smaller score.
measure: Gut microbiota (GM) analysis pre and post dietary therapy
time frame: At the end of 24 weeks of dietary therapy
description: Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM
measure: Change in behavioral abnormalities with each dietary therapy
time frame: At the end of 24 weeks of dietary therapy
description: Behavior assessment is done using Child behavior check list (CBCL).This questionnaire contains 100 and 113 questions for age groups of 1 ½ - 5 years and 6-18 years respectively. Score of 2 will be given for a response of 'very true', 1 for a response of 'somewhat true' and 0 for 'not true'. Total score is obtained by adding all the subsets. Subsets for age 1.5 years to 5 years include - Emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior and other problems. Subsets for age 6 years to 12 years include - Anxious/Depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, aggressive behavior, other problems. Raw score is then converted to T score according to the published charts. Minimum T score is 28 and maximum is 100. Larger score indicates more behavioral problems.
arm group label: Low Glycemic Index therapy
arm group type: Experimental
description: Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only
arm group label: Modified Atkins Diet
arm group type: Active Comparator
description: Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio
intervention type: Other
intervention name: Low glycemic Index Therapy (LGIT)
description: Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.
arm group label: Low Glycemic Index therapy
intervention type: Other
intervention name: Modified Atkins Diet (MAD)
description: Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.
arm group label: Modified Atkins Diet
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
last name: Sheffali Gulati, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, New Delhi
last name: Sheffali Gulati, MD
phone: 9810386847
email: sheffaligulati@gmail.com
last name: Vaishakh Anand, MD
phone: 7838528549
email: drvyshakhanandmp@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Sheffali Gulati
investigator title: Professor, Chief, Child Neurology Division
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: Undecided