<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/NCT02255942</url>
  </required_header>
  <id_info>
    <org_study_id>Rice-FePP-Zn</org_study_id>
    <nct_id>NCT02255942</nct_id>
  </id_info>
  <brief_title>The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate</brief_title>
  <acronym>Rice_FeZn</acronym>
  <official_title>The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric&#xD;
      Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves&#xD;
      as a Reference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to&#xD;
      fortify rice and other foods as it causes no organoleptic changes to the food vehicles.&#xD;
      However, it is only of low absorption in man and its absorption can be influenced by a&#xD;
      variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on&#xD;
      iron bioavailability in extruded rice fortified with FePP has never been investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the isotopic ratio of iron in blood at week 2</measure>
    <time_frame>baseline, 2 weeks</time_frame>
    <description>The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from week 2 in the isotopic ratio of iron in blood at week 4</measure>
    <time_frame>2 weeks, 4 weeks</time_frame>
    <description>The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from week 4 in the isotopic ratio of iron in blood at week 6</measure>
    <time_frame>4 weeks, 6 weeks</time_frame>
    <description>The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>baseline, 16th, 30th and 44th day</time_frame>
    <description>14 or 15 days after each meal administration and at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Ferritin</measure>
    <time_frame>baseline, 16th, 30th and 44th day</time_frame>
    <description>14 or 15 days after each meal administration and at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C reactive protein</measure>
    <time_frame>baseline, 16th, 30th and 44th day</time_frame>
    <description>14 or 15 days after each meal administration and at baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Iron fortified rice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ferric Pyrophosphate and Zinc Oxide</intervention_name>
    <description>Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)</description>
    <arm_group_label>Iron fortified rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ferrous sulfate</intervention_name>
    <description>Rice fortified with Ferrous Sulfate (ZnSO4)</description>
    <arm_group_label>Iron fortified rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ferric Pyrophosphate and Zinc Sulfate</intervention_name>
    <description>Rice fortified with Ferric Pyrophosphate and Zinc Sulfate</description>
    <arm_group_label>Iron fortified rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ferric Pyrophosphate</intervention_name>
    <description>Rice fortified with Ferric Pyrophosphate</description>
    <arm_group_label>Iron fortified rice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Serum Ferritin Level &lt; 15 µg/L&#xD;
&#xD;
          -  Body weight &lt;65 kg&#xD;
&#xD;
          -  Signed informed consent 4. Body Mass Index in the range of 18.5 to 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Zimmermann, Prof.Dr., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETH Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ETH Zürich, Laboratory of Human Nutrition</name>
      <address>
        <city>Zürich</city>
        <state>ZH</state>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</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>Prof. Michael B. Zimmermann</investigator_full_name>
    <investigator_title>Prof.Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc</mesh_term>
    <mesh_term>Iron</mesh_term>
    <mesh_term>Zinc Sulfate</mesh_term>
    <mesh_term>Zinc Oxide</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/NCT02255942
org study id: Rice-FePP-Zn
nct id: NCT02255942
lead sponsor: 
collaborator: 
has dmc: No
Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric
      Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves
      as a Reference.
Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to
      fortify rice and other foods as it causes no organoleptic changes to the food vehicles.
      However, it is only of low absorption in man and its absorption can be influenced by a
      variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on
      iron bioavailability in extruded rice fortified with FePP has never been investigated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
time frame: baseline, 2 weeks
description: The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
measure: Change from week 2 in the isotopic ratio of iron in blood at week 4
time frame: 2 weeks, 4 weeks
description: The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
measure: Change from week 4 in the isotopic ratio of iron in blood at week 6
time frame: 4 weeks, 6 weeks
description: The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
measure: Haemoglobin
time frame: baseline, 16th, 30th and 44th day
description: 14 or 15 days after each meal administration and at baseline
measure: Plasma Ferritin
time frame: baseline, 16th, 30th and 44th day
description: 14 or 15 days after each meal administration and at baseline
measure: C reactive protein
time frame: baseline, 16th, 30th and 44th day
description: 14 or 15 days after each meal administration and at baseline
arm group label: Iron fortified rice
arm group type: Experimental
description: Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
intervention type: Other
intervention name: Ferric Pyrophosphate and Zinc Oxide
description: Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
arm group label: Iron fortified rice
intervention type: Other
intervention name: Ferrous sulfate
description: Rice fortified with Ferrous Sulfate (ZnSO4)
arm group label: Iron fortified rice
intervention type: Other
intervention name: Ferric Pyrophosphate and Zinc Sulfate
description: Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
arm group label: Iron fortified rice
intervention type: Other
intervention name: Ferric Pyrophosphate
description: Rice fortified with Ferric Pyrophosphate
arm group label: Iron fortified rice
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Zimmermann, Prof.Dr., MD
role: Principal Investigator
affiliation: ETH Zürich
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Prof. Michael B. Zimmermann
investigator title: Prof.Dr.
mesh term: Iron Deficiencies
mesh term: Zinc
mesh term: Iron
mesh term: Zinc Sulfate
mesh term: Zinc Oxide