<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/NCT04407572</url>
  </required_header>
  <id_info>
    <org_study_id>zinc-dvit-covid19</org_study_id>
    <nct_id>NCT04407572</nct_id>
  </id_info>
  <brief_title>Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women</brief_title>
  <official_title>Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ayşegül Bestel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>İbrahim Polat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merve Aldıkaçtıoğlu Talmaç</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</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>
      Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms&#xD;
      of patients' responses to computed tomography and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated&#xD;
      together with the information of the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Actual">June 14, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum zinc, vitamin d vitamin b12 deficiency levels</measure>
    <time_frame>2 months</time_frame>
    <description>Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.</description>
  </primary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>COVID</condition>
  <condition>Zinc Deficiency</condition>
  <condition>Vitamin D Deficiency</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum zinc, vitamin d vitamin b12 levels .</intervention_name>
    <description>Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum zinc, vitamin d vitamin b12 levels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women between 18-45 years old with positive covid-19 pcr test results&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  covid-19 positive pregnant women&#xD;
&#xD;
          -  under 18 or more than 45 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vitamin D , Vitamin B12 or Zinc supplement use&#xD;
&#xD;
          -  Multivitamine use&#xD;
&#xD;
          -  have taken vitamin supplements in the past 3 months&#xD;
&#xD;
          -  use of medicines for vitamin deficiency&#xD;
&#xD;
          -  having metabolic disease covid-19 negative pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pinar Yalcin Bahat</name>
      <address>
        <city>Istanbul</city>
        <state>İ̇stanbul</state>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Yalcin bahat</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>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin B 12</mesh_term>
    <mesh_term>Hydroxocobalamin</mesh_term>
  </intervention_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/NCT04407572
org study id: zinc-dvit-covid19
nct id: NCT04407572
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms
      of patients' responses to computed tomography and treatment.
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated
      together with the information of the patients.
observational model: Case-Control
time perspective: Prospective
measure: Serum zinc, vitamin d vitamin b12 deficiency levels
time frame: 2 months
description: Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
intervention type: Other
intervention name: Serum zinc, vitamin d vitamin b12 levels .
description: Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
Serum zinc, vitamin d vitamin b12 levels
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Yalcin bahat
investigator title: Principal Investigator
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Vitamins
mesh term: Vitamin B 12
mesh term: Hydroxocobalamin
sharing ipd: Yes