<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/NCT03777904</url>
  </required_header>
  <id_info>
    <org_study_id>00117617</org_study_id>
    <nct_id>NCT03777904</nct_id>
  </id_info>
  <brief_title>The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels</brief_title>
  <official_title>The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      A serum ferritin level can reflect the total body iron content, thus a very low serum&#xD;
      ferritin is commonly used as an indicator of iron deficiency and a very high serum ferritin&#xD;
      is commonly used as a marker of iron overload. Ferritin is a shell of protein in which iron&#xD;
      is stored. Ferritin is an acute phase reactant, and serum ferritin levels can increase during&#xD;
      inflammatory conditions. Consequently, an elevated ferritin level might mean there is an&#xD;
      excess of storage iron, or might simply mean that inflammation has resulted in high levels of&#xD;
      the ferritin shell, containing little iron.&#xD;
&#xD;
      The research team is able to quantify the amount of iron in ferritin using inductively&#xD;
      conducted plasma mass spectrometry, in the Heme and Iron Core Laboratory at the University of&#xD;
      Utah. Thus, it can be determined whether in a child with a very high serum ferritin level,&#xD;
      that ferritin is loaded with iron or is actually very low in iron. Neonates and young&#xD;
      children with certain liver disorders characteristically have a very high serum ferritin&#xD;
      level. These conditions are gestational alloimmune liver disease (GALD) and hemophagocytic&#xD;
      lymphohistiocytosis (HLH). It is not clear what the iron content of the ferritin is in these&#xD;
      neonates. Knowing this will be a step toward understanding whether the pathogenesis of these&#xD;
      conditions involves iron overload. Additionally, if urine ferritin and iron levels correlate&#xD;
      with serum ferritin and iron levels, urine may be used as a non-invasive way to monitor iron&#xD;
      status.&#xD;
&#xD;
      In this study, serum and urine samples will be collected from children with high serum&#xD;
      ferritin levels and confirmed iron toxicity. Both ferritin and iron content within ferritin&#xD;
      will be measured in the serum and urine samples and compared for correlation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Analysis of first 11 subjects resulted in values that were too varied to make the study&#xD;
    feasible.&#xD;
  </why_stopped>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of serum and urine ferritin levels</measure>
    <time_frame>1 year</time_frame>
    <description>Serum levels of ferritin will be compared to urine ferritin levels to evaluate whether urine can be used to calculate ferritin levels in the body non-invasively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of iron content within serum and urine ferritin levels</measure>
    <time_frame>1 year</time_frame>
    <description>Serum iron content of ferritin will be compared to urine iron content of ferritin levels to evaluate whether urine can be used to calculate total body iron content non-invasively</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Iron Overload</condition>
  <arm_group>
    <arm_group_label>Children with high serum ferritin</arm_group_label>
    <description>Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum Ferritin level</intervention_name>
    <description>Serum ferritin level will be collected with other clinical labs and measured in the research lab</description>
    <arm_group_label>Children with high serum ferritin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum Ferritin iron content</intervention_name>
    <description>Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab</description>
    <arm_group_label>Children with high serum ferritin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urine Ferritin level</intervention_name>
    <description>Urine will be collected non-invasively and analyzed for ferritin level</description>
    <arm_group_label>Children with high serum ferritin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urine ferritin iron content</intervention_name>
    <description>Urine will be collected non-invasively and analyzed for iron content within the ferritin</description>
    <arm_group_label>Children with high serum ferritin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with high ferritin levels and confirmed iron toxicity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with ferritin levels &gt; 1000 ng/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Christensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Overload</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</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/NCT03777904
org study id: 00117617
nct id: NCT03777904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A serum ferritin level can reflect the total body iron content, thus a very low serum
      ferritin is commonly used as an indicator of iron deficiency and a very high serum ferritin
      is commonly used as a marker of iron overload. Ferritin is a shell of protein in which iron
      is stored. Ferritin is an acute phase reactant, and serum ferritin levels can increase during
      inflammatory conditions. Consequently, an elevated ferritin level might mean there is an
      excess of storage iron, or might simply mean that inflammation has resulted in high levels of
      the ferritin shell, containing little iron.

      The research team is able to quantify the amount of iron in ferritin using inductively
      conducted plasma mass spectrometry, in the Heme and Iron Core Laboratory at the University of
      Utah. Thus, it can be determined whether in a child with a very high serum ferritin level,
      that ferritin is loaded with iron or is actually very low in iron. Neonates and young
      children with certain liver disorders characteristically have a very high serum ferritin
      level. These conditions are gestational alloimmune liver disease (GALD) and hemophagocytic
      lymphohistiocytosis (HLH). It is not clear what the iron content of the ferritin is in these
      neonates. Knowing this will be a step toward understanding whether the pathogenesis of these
      conditions involves iron overload. Additionally, if urine ferritin and iron levels correlate
      with serum ferritin and iron levels, urine may be used as a non-invasive way to monitor iron
      status.

      In this study, serum and urine samples will be collected from children with high serum
      ferritin levels and confirmed iron toxicity. Both ferritin and iron content within ferritin
      will be measured in the serum and urine samples and compared for correlation.
observational model: Cohort
time perspective: Prospective
measure: Correlation of serum and urine ferritin levels
time frame: 1 year
description: Serum levels of ferritin will be compared to urine ferritin levels to evaluate whether urine can be used to calculate ferritin levels in the body non-invasively
measure: Correlation of iron content within serum and urine ferritin levels
time frame: 1 year
description: Serum iron content of ferritin will be compared to urine iron content of ferritin levels to evaluate whether urine can be used to calculate total body iron content non-invasively
arm group label: Children with high serum ferritin
description: Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.
intervention type: Diagnostic Test
intervention name: Serum Ferritin level
description: Serum ferritin level will be collected with other clinical labs and measured in the research lab
arm group label: Children with high serum ferritin
intervention type: Diagnostic Test
intervention name: Serum Ferritin iron content
description: Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab
arm group label: Children with high serum ferritin
intervention type: Diagnostic Test
intervention name: Urine Ferritin level
description: Urine will be collected non-invasively and analyzed for ferritin level
arm group label: Children with high serum ferritin
intervention type: Diagnostic Test
intervention name: Urine ferritin iron content
description: Urine will be collected non-invasively and analyzed for iron content within the ferritin
arm group label: Children with high serum ferritin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Robert Christensen, MD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Sponsor
mesh term: Iron Overload
mesh term: Iron