<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/NCT01687062</url>
  </required_header>
  <id_info>
    <org_study_id>EK2012N31</org_study_id>
    <nct_id>NCT01687062</nct_id>
  </id_info>
  <brief_title>Iron Absorption From Tef-injera in Women of Reproductive Age</brief_title>
  <official_title>Iron Absorption From Tef-injera in Women of Reproductive Age</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anemia is one of the most common health problems all over the world with around half of&#xD;
      preschool-aged children (&lt;5 years) and one third of women affected. Nutritional iron&#xD;
      deficiency is a major reason for anemia in infants, young children and women of reproductive&#xD;
      age who have especially high iron requirements that are difficult to meet in regions where&#xD;
      the major diet is based on plant foods. So in Ethiopia, where injera is the major staple&#xD;
      food. Despite high levels of iron in tef, the most favored cereal for injera, the iron&#xD;
      bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.&#xD;
&#xD;
      The aim of this study is to determine the iron bioavailability in women from injera prepared&#xD;
      in a traditional way and investigate the potential of methods to improve the bioavaiability.&#xD;
      Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be&#xD;
      evaluated. Further the potential positive impact of phytic acid reduction on the iron&#xD;
      bioavailability will be investigated. The phytic acid reduction will be achieved in two&#xD;
      different ways, by addition of whole grain wheat as source of phytase and addition of a&#xD;
      commercially available microbial phytase. The studies will be conducted in healthy women&#xD;
      using stable isotope techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron absorption</measure>
    <time_frame>17 days</time_frame>
    <description>Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>FeSO4 + high phytate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>injera test meal 1 labeled with a 4 mg staple iron isotope tag</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FeSO4 + medium phytate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injera test meal 2 labeled with a 4 mg staple iron isotope tag</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FeSO4 + low phytate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injera test meal 3 labeled with a 4 mg staple iron isotope tag</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FeSO4 + NaFeEDTA (1:1) + high phytate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injera test meal 4 labeled with a 4 mg staple iron isotope tag</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FeSO4 + NaFeEDTA (1:3) + high phytate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injera test meal 5 labeled with a 4 mg staple iron isotope tag</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FeSO4</intervention_name>
    <arm_group_label>FeSO4 + NaFeEDTA (1:1) + high phytate</arm_group_label>
    <arm_group_label>FeSO4 + NaFeEDTA (1:3) + high phytate</arm_group_label>
    <arm_group_label>FeSO4 + high phytate</arm_group_label>
    <arm_group_label>FeSO4 + low phytate</arm_group_label>
    <arm_group_label>FeSO4 + medium phytate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reduction of phytate</intervention_name>
    <arm_group_label>FeSO4 + low phytate</arm_group_label>
    <arm_group_label>FeSO4 + medium phytate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NaFeEDTA</intervention_name>
    <arm_group_label>FeSO4 + NaFeEDTA (1:1) + high phytate</arm_group_label>
    <arm_group_label>FeSO4 + NaFeEDTA (1:3) + high phytate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reproductive age females 18-40 years&#xD;
&#xD;
          -  Maximum body weight 65 kg&#xD;
&#xD;
          -  Normal body mass index (18.5-25 kg/m2)&#xD;
&#xD;
          -  No intake of mineral/vitamin supplements 2 weeks before and during the study&#xD;
&#xD;
          -  No metabolic or gastrointestinal disorders or chronic diseases&#xD;
&#xD;
          -  Not pregnant or lactating&#xD;
&#xD;
          -  No regular intake of medication (except oral contraceptives)&#xD;
&#xD;
          -  No blood donation or significant blood loss (accident, surgery) over the past 4 months&#xD;
&#xD;
          -  Not currently participating in another clinical trial or having participated in&#xD;
             another clinical trial during the last 3 months prior to the beginning of this study&#xD;
&#xD;
          -  No former participation in a study involving administration of iron stable isotopes&#xD;
&#xD;
          -  No eating disorders or food allergy&#xD;
&#xD;
          -  Subject who can be expected and are willing to comply with study protocol&#xD;
&#xD;
          -  Having received oral and written information about the aims and procedures of the&#xD;
             study&#xD;
&#xD;
          -  Having provided oral and written informed consent&#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>
  <location>
    <facility>
      <name>ETH Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>October 11, 2013</last_update_submitted>
  <last_update_submitted_qc>October 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2013</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>
  <keyword>NaFeEDTA</keyword>
  <keyword>phytate</keyword>
  <keyword>injera</keyword>
  <keyword>iron absorption</keyword>
  <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>Fe(III)-EDTA</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/NCT01687062
org study id: EK2012N31
nct id: NCT01687062
lead sponsor: 
has dmc: No
Anemia is one of the most common health problems all over the world with around half of
      preschool-aged children (<5 years) and one third of women affected. Nutritional iron
      deficiency is a major reason for anemia in infants, young children and women of reproductive
      age who have especially high iron requirements that are difficult to meet in regions where
      the major diet is based on plant foods. So in Ethiopia, where injera is the major staple
      food. Despite high levels of iron in tef, the most favored cereal for injera, the iron
      bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

      The aim of this study is to determine the iron bioavailability in women from injera prepared
      in a traditional way and investigate the potential of methods to improve the bioavaiability.
      Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be
      evaluated. Further the potential positive impact of phytic acid reduction on the iron
      bioavailability will be investigated. The phytic acid reduction will be achieved in two
      different ways, by addition of whole grain wheat as source of phytase and addition of a
      commercially available microbial phytase. The studies will be conducted in healthy women
      using stable isotope techniques.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Iron absorption
time frame: 17 days
description: Test meals with isotopic iron labels will be administrated on day 1-3. Whole blood samples will be collected on day 17 (14 after the last test meal) to analyze the iron isotope ratios.
arm group label: FeSO4 + high phytate
arm group type: Active Comparator
description: injera test meal 1 labeled with a 4 mg staple iron isotope tag
arm group label: FeSO4 + medium phytate
arm group type: Experimental
description: injera test meal 2 labeled with a 4 mg staple iron isotope tag
arm group label: FeSO4 + low phytate
arm group type: Experimental
description: injera test meal 3 labeled with a 4 mg staple iron isotope tag
arm group label: FeSO4 + NaFeEDTA (1:1) + high phytate
arm group type: Experimental
description: injera test meal 4 labeled with a 4 mg staple iron isotope tag
arm group label: FeSO4 + NaFeEDTA (1:3) + high phytate
arm group type: Experimental
description: injera test meal 5 labeled with a 4 mg staple iron isotope tag
intervention type: Other
intervention name: FeSO4
arm group label: FeSO4 + NaFeEDTA (1:1) + high phytate
arm group label: FeSO4 + NaFeEDTA (1:3) + high phytate
arm group label: FeSO4 + high phytate
arm group label: FeSO4 + low phytate
arm group label: FeSO4 + medium phytate
intervention type: Other
intervention name: reduction of phytate
arm group label: FeSO4 + low phytate
arm group label: FeSO4 + medium phytate
intervention type: Other
intervention name: NaFeEDTA
arm group label: FeSO4 + NaFeEDTA (1:1) + high phytate
arm group label: FeSO4 + NaFeEDTA (1:3) + high phytate
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
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: Fe(III)-EDTA