<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/NCT02979132</url>
  </required_header>
  <id_info>
    <org_study_id>Fe_LTL_Swi</org_study_id>
    <nct_id>NCT02979132</nct_id>
  </id_info>
  <brief_title>Iron Long-Term Labelling Study Switzerland</brief_title>
  <official_title>Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Michael B. Zimmermann</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>
      Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,&#xD;
      are confounded by inflammation from common infections and are therefore of limited use in&#xD;
      populations carrying a high burden of infection and inflammation, as for example women of&#xD;
      reproductive age in malaria endemic areas in developing countries. Even without the&#xD;
      confounding effect of inflammation, current markers of iron status are insensitive to small&#xD;
      changes in dietary iron and do not allow to establish associations between dietary, lifestyle&#xD;
      and genetic factors and iron balance. With a new method based on the dilution of a previously&#xD;
      administered and equilibrated stable isotope signal, an accurate measurement of long-term&#xD;
      oral iron balance and absorption is possible, allowing the estimation of iron requirements&#xD;
      and potentially providing fundamental guidance for supplementation and fortification programs&#xD;
      in both healthy and chronically inflamed/infected patients. In the current study the novel&#xD;
      methodology will be validated in generally healthy subjects with low iron status. The&#xD;
      technique will be used to assess dietary and lifestyle determinants of iron status and to&#xD;
      compare the effect on iron balance and iron status of three distinct, commonly used iron&#xD;
      interventions: food fortification with iron; oral iron supplementation, and intravenous iron&#xD;
      infusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>iron isotope composition in blood</measure>
    <time_frame>9 months</time_frame>
    <description>tracer to tracee rate in venous blood samples at different time points</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Iron Absorption</condition>
  <arm_group>
    <arm_group_label>Oral Iron Supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eisensulfat LOMAPHARM 50 mg administration for 90 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Iron Supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single-dose Ferinject(R) administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Food Fortification with Iron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eisensulfat LOMAPHARM 50 mg</intervention_name>
    <description>oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days</description>
    <arm_group_label>Oral Iron Supplementation</arm_group_label>
    <other_name>Eisentabletten</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferinject(R)</intervention_name>
    <description>Single-dose Ferinject(R) administration</description>
    <arm_group_label>Intravenous Iron Supplementation</arm_group_label>
    <other_name>Iron Infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>iron fortified biscuits</intervention_name>
    <description>consumption of an iron-fortfied biscuit every morning for 90 days</description>
    <arm_group_label>Food Fortification with Iron</arm_group_label>
    <other_name>HUG-Biskuits</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have participated in a former absorption study in our lab,&#xD;
&#xD;
          -  Signed written informed consent to participate in the new study,&#xD;
&#xD;
          -  Serum ferritin &lt; 25 µg/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anaemia (Hb &lt; 117 g/L),&#xD;
&#xD;
          -  Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal&#xD;
             failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular&#xD;
             diseases (according to the participants own statement),&#xD;
&#xD;
          -  Allergic or similar reactions against iron supplements,&#xD;
&#xD;
          -  Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase&#xD;
             deficiency,&#xD;
&#xD;
          -  Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)&#xD;
&#xD;
          -  Continuous/long-term use of medication during the whole study (except for&#xD;
             contraceptives),&#xD;
&#xD;
          -  Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st&#xD;
             supplement administration (more than 3 consecutive days or more than 5 times within 14&#xD;
             days),&#xD;
&#xD;
          -  Blood transfusion, blood donation or significant blood loss (accident, surgery) over&#xD;
             the past 6 months,&#xD;
&#xD;
          -  pregnancy or breast feeding,&#xD;
&#xD;
          -  Intention to become pregnant during the course of the study,&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse,&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant,&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study,&#xD;
&#xD;
          -  Enrollment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Nutrition Laboratory, ETH Zürich</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Federal Institute of Technology</investigator_affiliation>
    <investigator_full_name>Prof. Michael B. Zimmermann</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</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/NCT02979132
org study id: Fe_LTL_Swi
nct id: NCT02979132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers,
      are confounded by inflammation from common infections and are therefore of limited use in
      populations carrying a high burden of infection and inflammation, as for example women of
      reproductive age in malaria endemic areas in developing countries. Even without the
      confounding effect of inflammation, current markers of iron status are insensitive to small
      changes in dietary iron and do not allow to establish associations between dietary, lifestyle
      and genetic factors and iron balance. With a new method based on the dilution of a previously
      administered and equilibrated stable isotope signal, an accurate measurement of long-term
      oral iron balance and absorption is possible, allowing the estimation of iron requirements
      and potentially providing fundamental guidance for supplementation and fortification programs
      in both healthy and chronically inflamed/infected patients. In the current study the novel
      methodology will be validated in generally healthy subjects with low iron status. The
      technique will be used to assess dietary and lifestyle determinants of iron status and to
      compare the effect on iron balance and iron status of three distinct, commonly used iron
      interventions: food fortification with iron; oral iron supplementation, and intravenous iron
      infusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: iron isotope composition in blood
time frame: 9 months
description: tracer to tracee rate in venous blood samples at different time points
arm group label: Oral Iron Supplementation
arm group type: Active Comparator
description: Eisensulfat LOMAPHARM 50 mg administration for 90 days
arm group label: Intravenous Iron Supplementation
arm group type: Active Comparator
description: Single-dose Ferinject(R) administration
arm group label: Food Fortification with Iron
arm group type: Active Comparator
description: Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d
intervention type: Drug
intervention name: Eisensulfat LOMAPHARM 50 mg
description: oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days
arm group label: Oral Iron Supplementation
other name: Eisentabletten
intervention type: Drug
intervention name: Ferinject(R)
description: Single-dose Ferinject(R) administration
arm group label: Intravenous Iron Supplementation
other name: Iron Infusion
intervention type: Dietary Supplement
intervention name: iron fortified biscuits
description: consumption of an iron-fortfied biscuit every morning for 90 days
arm group label: Food Fortification with Iron
other name: HUG-Biskuits
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Prof. Michael B. Zimmermann
investigator title: Professor
mesh term: Iron
sharing ipd: Undecided