<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/NCT02982824</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU M.S 20/2016</org_study_id>
    <nct_id>NCT02982824</nct_id>
  </id_info>
  <brief_title>Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy</brief_title>
  <official_title>Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug&#xD;
      resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams&#xD;
      University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs&#xD;
      AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at&#xD;
      base line and after 6 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Aim of this work was to study the effect of Magnesium as add on therapy on clinical&#xD;
      seizure control in drug resistant idiopathic epilepsy and IQ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seizure control</measure>
    <time_frame>6 months</time_frame>
    <description>Change from base line seizure frequency, severity (Chalfont scale) at 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IQ improvement</measure>
    <time_frame>6-months</time_frame>
    <description>Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Drug Resistant Epilepsy</condition>
  <arm_group>
    <arm_group_label>Magnesium add-on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen &amp; Sander, 2012) for 6 months and their regular antiepileptic drugs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antiepileptic drugs only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To asses serum magnesium level for comparison with the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnesium</intervention_name>
    <description>Oral magnesium</description>
    <arm_group_label>Magnesium add-on</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Concentrate</intervention_name>
    <description>Placebo will be given</description>
    <arm_group_label>Antiepileptic drugs only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with drug resistant idiopathic epilepsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Structural, Metabolic, Infectious and Unknown etiology epilepsy&#xD;
&#xD;
          -  Any neurological disease other than epilepsy&#xD;
&#xD;
          -  Any nutritional disorder&#xD;
&#xD;
          -  Any other systemic diseases (including Renal disease, Cardiac arrhythmia)&#xD;
&#xD;
          -  Drug intake other than antiepileptic drugs (AED)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sahar MA Hassanein, PhD. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrics, Faculty of Medicine, Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital, Faculty of Medicine, Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>11381</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.</citation>
    <PMID>16788707</PMID>
  </reference>
  <reference>
    <citation>Osborn KE, Shytle RD, Frontera AT, Soble JR, Schoenberg MR. Addressing potential role of magnesium dyshomeostasis to improve treatment efficacy for epilepsy: A reexamination of the literature. J Clin Pharmacol. 2016 Mar;56(3):260-5. doi: 10.1002/jcph.626. Epub 2015 Oct 26.</citation>
    <PMID>26313363</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 7, 2017</last_update_submitted>
  <last_update_submitted_qc>May 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Sahar M.A. Hassanein, MD</investigator_full_name>
    <investigator_title>Professor of Pediatrics and Head of Pediatric Neurology Unit, Children's</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>IQ</keyword>
  <keyword>Idiopathic epilepsy</keyword>
  <keyword>Magnesium supplementation</keyword>
  <keyword>Seizure control</keyword>
  <keyword>Chalfont score</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>Yes</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/NCT02982824
org study id: FMASU M.S 20/2016
nct id: NCT02982824
lead sponsor: 
has dmc: Yes
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug
      resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams
      University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs
      AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at
      base line and after 6 months of treatment.
The Aim of this work was to study the effect of Magnesium as add on therapy on clinical
      seizure control in drug resistant idiopathic epilepsy and IQ.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Seizure control
time frame: 6 months
description: Change from base line seizure frequency, severity (Chalfont scale) at 6 months.
measure: IQ improvement
time frame: 6-months
description: Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
arm group label: Magnesium add-on
arm group type: Experimental
description: 20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen & Sander, 2012) for 6 months and their regular antiepileptic drugs.
arm group label: Antiepileptic drugs only
arm group type: Placebo Comparator
description: 20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.
arm group label: Healthy controls
arm group type: No Intervention
description: To asses serum magnesium level for comparison with the intervention group.
intervention type: Dietary Supplement
intervention name: Magnesium
description: Oral magnesium
arm group label: Magnesium add-on
intervention type: Drug
intervention name: Placebo - Concentrate
description: Placebo will be given
arm group label: Antiepileptic drugs only
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Sahar MA Hassanein, PhD. MD
role: Principal Investigator
affiliation: Pediatrics, Faculty of Medicine, Ain Shams University
facility: 
country: Egypt
citation: Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
PMID: 16788707
citation: Osborn KE, Shytle RD, Frontera AT, Soble JR, Schoenberg MR. Addressing potential role of magnesium dyshomeostasis to improve treatment efficacy for epilepsy: A reexamination of the literature. J Clin Pharmacol. 2016 Mar;56(3):260-5. doi: 10.1002/jcph.626. Epub 2015 Oct 26.
PMID: 26313363
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Sahar M.A. Hassanein, MD
investigator title: Professor of Pediatrics and Head of Pediatric Neurology Unit, Children's
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: Yes