<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/NCT04488172</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-105-489</org_study_id>
    <nct_id>NCT04488172</nct_id>
  </id_info>
  <brief_title>Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy</brief_title>
  <official_title>Exploring the Effects of Genetic Variants and Inflammation on Individualized Treatment Outcomes of Vitamins Supplementation in Patient With Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The management of patients with epilepsy is focused on controlling seizures, avoiding&#xD;
      treatment side effects, and restoring quality of life. However, about 30% of people are&#xD;
      antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs&#xD;
      treatment. Genetic factors may contribute to the high interindividual variability in response&#xD;
      or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more,&#xD;
      previous observational studies indicated that vitamin deficiency, such as vitamin B6, is&#xD;
      common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore,&#xD;
      investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins&#xD;
      supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and&#xD;
      multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current study, investigators will evaluate the association among the genetic&#xD;
      polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will&#xD;
      further investigate potential genes related to vitamins signal pathways (especially vitamin&#xD;
      B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of&#xD;
      AEDs pharmacogenomics for further study, but also provide new potential treatment targets&#xD;
      that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity,&#xD;
      body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and&#xD;
      depression scores. All outcome indicators will be repeated measured at baseline and after 1,&#xD;
      3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the&#xD;
      genotypes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 7, 2015</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Seizure severity</measure>
    <time_frame>6 months</time_frame>
    <description>Number of seizure attack per month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Compliance</measure>
    <time_frame>6 months</time_frame>
    <description>Assessing using Morisky Medication Adherence Scale (MMAS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Epilepsy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multi-vitamin supplementation</intervention_name>
    <description>Vitamin B6:100 mg/day Vitamin B9: 5 mg/day Vitamin D: 1000 IU/day Vitamin E: 400 IU/day Co-Q10: 100 mg/day</description>
    <arm_group_label>Epilepsy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic criteria of epilepsy&#xD;
&#xD;
          -  Receive anti-epileptic drugs (AEDs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an organic mental disorder, mental retardation, dementia, or other diagnosed&#xD;
             neurological illness&#xD;
&#xD;
          -  Have a surgical condition or a major physical illness&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hui Hua Chang, Ph.D</last_name>
    <phone>886-6-2353535</phone>
    <phone_ext>5683</phone_ext>
    <email>huihua@mail.ncku.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cheng Kung University (NCKU) Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Hua Chang, PhD</last_name>
      <phone>886-2353535</phone>
      <phone_ext>5683</phone_ext>
      <email>huihua@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacogenomics</keyword>
  <keyword>antiepileptic drugs</keyword>
  <keyword>multi-vitamins supplementation</keyword>
  <keyword>epilepsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_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/NCT04488172
org study id: A-ER-105-489
nct id: NCT04488172
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The management of patients with epilepsy is focused on controlling seizures, avoiding
      treatment side effects, and restoring quality of life. However, about 30% of people are
      antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs
      treatment. Genetic factors may contribute to the high interindividual variability in response
      or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more,
      previous observational studies indicated that vitamin deficiency, such as vitamin B6, is
      common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore,
      investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins
      supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and
      multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.
In the current study, investigators will evaluate the association among the genetic
      polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will
      further investigate potential genes related to vitamins signal pathways (especially vitamin
      B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of
      AEDs pharmacogenomics for further study, but also provide new potential treatment targets
      that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity,
      body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and
      depression scores. All outcome indicators will be repeated measured at baseline and after 1,
      3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the
      genotypes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Seizure severity
time frame: 6 months
description: Number of seizure attack per month
measure: Medication Compliance
time frame: 6 months
description: Assessing using Morisky Medication Adherence Scale (MMAS)
arm group label: Epilepsy subjects
arm group type: Experimental
description: Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial
intervention type: Dietary Supplement
intervention name: Multi-vitamin supplementation
description: Vitamin B6:100 mg/day Vitamin B9: 5 mg/day Vitamin D: 1000 IU/day Vitamin E: 400 IU/day Co-Q10: 100 mg/day
arm group label: Epilepsy subjects
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hui Hua Chang, Ph.D
phone: 886-6-2353535
phone ext: 5683
email: huihua@mail.ncku.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Inflammation
mesh term: Vitamins