<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/NCT03040219</url>
  </required_header>
  <id_info>
    <org_study_id>27111982</org_study_id>
    <nct_id>NCT03040219</nct_id>
  </id_info>
  <brief_title>Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children</brief_title>
  <official_title>Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Folic acid as a appetizer in primary malnutrition&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appetite</measure>
    <time_frame>Through study completion_ after 3 months from start of supplementation</time_frame>
    <description>Child eating behaviour questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leptin and ghrelin hormone</measure>
    <time_frame>3 months</time_frame>
    <description>Serum level</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Growth</measure>
    <time_frame>Through study completion -after 3 months from start of supplementation</time_frame>
    <description>Anthropometric study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Primary Malnurtrition</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary malnourished children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous folic supplementation in the past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marian Girgis</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marian Girgis</last_name>
    <phone>0201223646224</phone>
    <email>Mariangirgis2009@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Marian girgis</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Marian Girgis</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>March 11, 2017</last_update_submitted>
  <last_update_submitted_qc>March 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Marian girgis</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
  </intervention_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/NCT03040219
org study id: 27111982
nct id: NCT03040219
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Folic acid as a appetizer in primary malnutrition
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Appetite
time frame: Through study completion_ after 3 months from start of supplementation
description: Child eating behaviour questionnaire
measure: Leptin and ghrelin hormone
time frame: 3 months
description: Serum level
measure: Growth
time frame: Through study completion -after 3 months from start of supplementation
description: Anthropometric study
arm group label: Treatment group
arm group type: Active Comparator
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Folic Acid
description: Tablets
arm group label: Control
arm group label: Treatment group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marian Girgis
role: Principal Investigator
affiliation: Ain Shams University
last name: Marian Girgis
phone: 0201223646224
email: Mariangirgis2009@yahoo.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Marian girgis
investigator title: Principal investigator
mesh term: Malnutrition
mesh term: Folic Acid
sharing ipd: Undecided