<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/NCT02993835</url>
  </required_header>
  <id_info>
    <org_study_id>16.15.NRC</org_study_id>
    <nct_id>NCT02993835</nct_id>
  </id_info>
  <brief_title>Iron Bioavailability From Fortified Food</brief_title>
  <official_title>Iron Bioavailability From Fortified Food in Healthy Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determination of fractional iron absorption from bouillon fortified with 3 labeled iron&#xD;
      compounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single center trial will be single-blind to the subject, controlled, fully randomized&#xD;
      with crossover design in 22 healthy females aged 18-40 years old.&#xD;
&#xD;
      Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days&#xD;
      after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after&#xD;
      last stable isotope intake blood sampling (V7).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation.</measure>
    <time_frame>14 days after last stable isotope adminstration</time_frame>
    <description>FIA will be calculated based on the measured shift of iron isotope ratios in the blood 14 days after the test meal administrations. The amounts of 57Fe, 54Fe and 58Fe in the blood will be calculated on the principle of isotope dilution by considering that iron isotopic labels are not mono-isotopic (Walczyk et al., 1997; Cercamondi, 2013). Circulating iron will be calculated based on blood volume and hemoglobin concentration (Kastenmayer et al., 1994). Blood volume will be indirectly measured based on height and weight and calculated using the formula proposed by Brown et al (1962). For calculations of fractional absorption, 80% incorporation of the absorbed iron into red blood cells is assumed.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Iron Bioavailability</condition>
  <arm_group>
    <arm_group_label>Labeled iron salt (Fe54)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Labeled iron salt (Fe54) with bouillon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Labeled iron salt (Fe57)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Labeled iron salt (Fe57) with bouillon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Labeled iron salt (Fe58)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Labeled iron salt (Fe58) with bouillon</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe54</intervention_name>
    <description>Fe salt enriched with Fe 54 isotopes</description>
    <arm_group_label>Labeled iron salt (Fe54)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe57</intervention_name>
    <description>Fe salt enriched with Fe 57 isotopes</description>
    <arm_group_label>Labeled iron salt (Fe57)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe58</intervention_name>
    <description>Fe salt enriched with Fe 58 isotopes</description>
    <arm_group_label>Labeled iron salt (Fe58)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged 18-40 years old&#xD;
&#xD;
          2. Healthy, based on the medical screening visit including a blood formula&#xD;
&#xD;
          3. Normal BMI for age (18.5-25.0 kg/m2)&#xD;
&#xD;
          4. Weight less than 65 kg&#xD;
&#xD;
          5. Able to understand and to sign written informed consent prior to trial entry&#xD;
&#xD;
          6. Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anemia or polycythemia respectively evidenced by one of the following criteria from a&#xD;
             standard blood formula: number of erythrocytes 4.0 - 5.8 1012/l or Hb 120-160 g/l or&#xD;
             Ht 35-55%. Subjects outside of this range will be excluded.&#xD;
&#xD;
          2. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood&#xD;
             donation and other causes to be appreciated by the investigator).&#xD;
&#xD;
          3. Serum ferritin above 80 µg/L range. As a result, hemochromatosis will be excluded.&#xD;
&#xD;
          4. Any therapy or medication taken for any infectious and inflammatory disease in the&#xD;
             past two weeks.&#xD;
&#xD;
          5. Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic&#xD;
             disease, as determined by the screening visit and by self-report from the subjects.&#xD;
&#xD;
          6. Diagnosed food allergy.&#xD;
&#xD;
          7. Pregnancy (tested in plasma at screening) and/or lactation.&#xD;
&#xD;
          8. History of cancer within the past year.&#xD;
&#xD;
          9. Significant weight loss during the last 3 months (10% and more)&#xD;
&#xD;
         10. Any medication or supplement which may impact erythrocytes, Hb or Ht (to the opinion&#xD;
             of the investigator).&#xD;
&#xD;
         11. Iron supplementation therapy or perfusion in the last three months.&#xD;
&#xD;
         12. Smokers (&gt; 5 cigarettes per day).&#xD;
&#xD;
         13. Have a high alcohol consumption (more than 2 drinks/day).&#xD;
&#xD;
         14. Consumption of illicit drugs (anamnesis only).&#xD;
&#xD;
         15. Subject having a hierarchical link with the investigator or co-investigators.&#xD;
&#xD;
         16. Subject who cannot be expected to comply with treatment or study procedure.&#xD;
&#xD;
         17. Currently participating or having participated in another clinical trial during the&#xD;
             past month prior to the beginning of this study.&#xD;
&#xD;
         18. Subjects not willing and/or not able to comply with scheduled visits and the&#xD;
             requirements of the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diego Moretti, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETH Zurich, Human Nutrition Laboratory</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ETH Zurich, Human Nutrition Laboratory</name>
      <address>
        <city>Zurich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>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/NCT02993835
org study id: 16.15.NRC
nct id: NCT02993835
lead sponsor: 
has dmc: No
Determination of fractional iron absorption from bouillon fortified with 3 labeled iron
      compounds.
This single center trial will be single-blind to the subject, controlled, fully randomized
      with crossover design in 22 healthy females aged 18-40 years old.

      Subjects will attend 8 visits. At screening (V0), 3 consecutive feeding days (V1-V3), 14 days
      after last stable isotope intake again 3 consecutive feeding days (V4-V6), and 14 days after
      last stable isotope intake blood sampling (V7).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Relative iron bioavailability (RBV) of 58Fe salt to 54Fe salt (i.e. FIA of 58Fe salt divided by FIA of 54Fe salt), RBV of 57Fe salt to 54Fe salt and RBV of 58Fe salt to 57Fe salt. The determination of FIA is a prerequisite for this calculation.
time frame: 14 days after last stable isotope adminstration
description: FIA will be calculated based on the measured shift of iron isotope ratios in the blood 14 days after the test meal administrations. The amounts of 57Fe, 54Fe and 58Fe in the blood will be calculated on the principle of isotope dilution by considering that iron isotopic labels are not mono-isotopic (Walczyk et al., 1997; Cercamondi, 2013). Circulating iron will be calculated based on blood volume and hemoglobin concentration (Kastenmayer et al., 1994). Blood volume will be indirectly measured based on height and weight and calculated using the formula proposed by Brown et al (1962). For calculations of fractional absorption, 80% incorporation of the absorbed iron into red blood cells is assumed.
arm group label: Labeled iron salt (Fe54)
arm group type: Active Comparator
description: Labeled iron salt (Fe54) with bouillon
arm group label: Labeled iron salt (Fe57)
arm group type: Active Comparator
description: Labeled iron salt (Fe57) with bouillon
arm group label: Labeled iron salt (Fe58)
arm group type: Experimental
description: Labeled iron salt (Fe58) with bouillon
intervention type: Other
intervention name: Labeled iron salt Fe54
description: Fe salt enriched with Fe 54 isotopes
arm group label: Labeled iron salt (Fe54)
intervention type: Other
intervention name: Labeled iron salt Fe57
description: Fe salt enriched with Fe 57 isotopes
arm group label: Labeled iron salt (Fe57)
intervention type: Other
intervention name: Labeled iron salt Fe58
description: Fe salt enriched with Fe 58 isotopes
arm group label: Labeled iron salt (Fe58)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diego Moretti, PhD
role: Principal Investigator
affiliation: ETH Zurich, Human Nutrition Laboratory
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Iron
sharing ipd: No