<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/NCT03816813</url>
  </required_header>
  <id_info>
    <org_study_id>HepSa</org_study_id>
    <nct_id>NCT03816813</nct_id>
  </id_info>
  <brief_title>Assessement of Hepcidin in Saliva in Human Volunteers</brief_title>
  <official_title>Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Federal Institute of Technology</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>
      Iron deficiency with or without anemia is considered the most widespread nutritional&#xD;
      deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin&#xD;
      measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive&#xD;
      fluid for disease biomarker discovery and diagnostic efforts, because it is readily available&#xD;
      from most individuals, can be easily collected and the collection procedure is non-invasive.&#xD;
      The iron storage protein ferritin is too big, to be secreted into saliva. However, the main&#xD;
      iron regulatory protein hepcidin is a very small protein and there is some evidence for&#xD;
      hepcidin detection in saliva. The production of serum hepcidin positively correlates with&#xD;
      serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in&#xD;
      saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs&#xD;
      to be tested.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Saliva hepcidin</measure>
    <time_frame>Day 1am</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum hepcidin</measure>
    <time_frame>Day 1am</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum ferritin</measure>
    <time_frame>Day 1am</time_frame>
    <description>Iron Status parameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>Day 1am</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transferrin receptor</measure>
    <time_frame>Day 1am</time_frame>
    <description>Iron Status parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>c-reactive protein</measure>
    <time_frame>Day 1am</time_frame>
    <description>Inflammation parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alpha-glycoprotein</measure>
    <time_frame>Day 1am</time_frame>
    <description>Inflammation parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva hepcidin</measure>
    <time_frame>Day 1pm</time_frame>
    <description>to assess variability in saliva hepcidin during the day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva hepcidin</measure>
    <time_frame>Day 2am</time_frame>
    <description>to assess variability in saliva hepcidin in two samples measured at the same time of the day</description>
  </secondary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Hepcidin, Saliva</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood and saliva sampling</intervention_name>
    <description>blood and saliva sampling</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy volunteers, male and female&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal-weight (BMI 18-24.9kg/m2)&#xD;
&#xD;
          -  fasting&#xD;
&#xD;
          -  Participants Need to have brushed their teeth at least 1 hour before the visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute, chronic illness&#xD;
&#xD;
          -  use of long-term medication other than contraception&#xD;
&#xD;
          -  medical Problems known to affect Fe homeostasis&#xD;
&#xD;
          -  smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Laboratory of Human Nutrition</name>
      <address>
        <city>Zürich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
    <investigator_full_name>Diego Moretti</investigator_full_name>
    <investigator_title>PhD, Senior Scientist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03816813
org study id: HepSa
nct id: NCT03816813
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Iron deficiency with or without anemia is considered the most widespread nutritional
      deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin
      measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive
      fluid for disease biomarker discovery and diagnostic efforts, because it is readily available
      from most individuals, can be easily collected and the collection procedure is non-invasive.
      The iron storage protein ferritin is too big, to be secreted into saliva. However, the main
      iron regulatory protein hepcidin is a very small protein and there is some evidence for
      hepcidin detection in saliva. The production of serum hepcidin positively correlates with
      serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in
      saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs
      to be tested.
observational model: Cohort
time perspective: Cross-Sectional
measure: Saliva hepcidin
time frame: Day 1am
measure: Serum hepcidin
time frame: Day 1am
measure: Serum ferritin
time frame: Day 1am
description: Iron Status parameter
measure: Hemoglobin
time frame: Day 1am
measure: Transferrin receptor
time frame: Day 1am
description: Iron Status parameter
measure: c-reactive protein
time frame: Day 1am
description: Inflammation parameter
measure: alpha-glycoprotein
time frame: Day 1am
description: Inflammation parameter
measure: Saliva hepcidin
time frame: Day 1pm
description: to assess variability in saliva hepcidin during the day
measure: Saliva hepcidin
time frame: Day 2am
description: to assess variability in saliva hepcidin in two samples measured at the same time of the day
intervention type: Other
intervention name: blood and saliva sampling
description: blood and saliva sampling
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Diego Moretti
investigator title: PhD, Senior Scientist
sharing ipd: No