<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/NCT03840031</url>
  </required_header>
  <id_info>
    <org_study_id>SASHA-II</org_study_id>
    <nct_id>NCT03840031</nct_id>
  </id_info>
  <brief_title>Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato</brief_title>
  <acronym>SASHA-II</acronym>
  <official_title>SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malawi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based&#xD;
      solutions have to be implemented to serve populations, not only individuals. One solution is&#xD;
      the introduction of iron biofortified staple crops on market level. Before market level&#xD;
      introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato&#xD;
      (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and&#xD;
      total iron absorption after extrinsic stable isotope labelling of the new biofortified high&#xD;
      iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian&#xD;
      women of reproductive age with marginal iron status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron&#xD;
      sweet potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the&#xD;
      test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57&#xD;
      for a period of 10 days. The order of test meal type is random. A baseline blood sample will&#xD;
      be taken on the first meal feeding day prior to consumption of any test meals, on study day&#xD;
      26 (14 days after completion of the first test meal period) and on Day 40 (14 days after&#xD;
      completion of the second test meal period). Erythrocyte incorporation of the stable isotope&#xD;
      labels will be measured in these blood samples using an ICPMS and will be used to calculate&#xD;
      fractional and total iron absorption from the two different type of test meals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</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>
    <intervention_model_description>Each woman consumes both Orange Fleshed Sweet Potato varieties</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant is blinded, meal option A --&gt; B or B --&gt; A based on investigator randomisation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional iron absorption from both Orange Fleshed Sweet Potato varieties</measure>
    <time_frame>Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.</time_frame>
    <description>Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total iron absorption from both Orange Fleshed Sweet Potato varieties</measure>
    <time_frame>Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.</time_frame>
    <description>Amount of iron absorbed (mg) from the labelled test meals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma ferritin level</measure>
    <time_frame>screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)</time_frame>
    <description>Iron status marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of plasma CRP level</measure>
    <time_frame>screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)</time_frame>
    <description>Inflammation status marker</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Orange Fleshed Sweet Potato High Iron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meal sequence B, OFSP High Fe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange Fleshed Sweet Potato Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Meal sequence A, OFSP control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Fe OFSP meal labelled with Fe-58</intervention_name>
    <description>400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days</description>
    <arm_group_label>Orange Fleshed Sweet Potato High Iron</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control OFSP meal labelled with Fe-57</intervention_name>
    <description>400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days</description>
    <arm_group_label>Orange Fleshed Sweet Potato Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Woman aged 18-35 years old&#xD;
&#xD;
          2. low/marginal iron status respectively evidenced by one of the following criteria: PF ≤&#xD;
             25 µg/L&#xD;
&#xD;
          3. Normal BMI for age (18.5-25.0 kg/m2)&#xD;
&#xD;
          4. Weight less than 65 kg. A maximum weight limitation is needed since the stable isotope&#xD;
             portions are based on body weight. We want to give equal amounts of stable isotopes to&#xD;
             each study participant and therefore need to standardize body weight.&#xD;
&#xD;
          5. Living in a study radius of 30 km from the meal distribution/ health centre side&#xD;
&#xD;
          6. Willing and able to commute to the set meal distribution/ health centre side&#xD;
&#xD;
          7. Able to understand and to sign* written concept prior to trial entry&#xD;
&#xD;
          8. Informed consent signed * Signing of informed consent by either autograph or finger&#xD;
             print.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe anaemia Hb &lt;80 g/l&#xD;
&#xD;
          2. High infection rate based on CRP &gt; 5 mg/L&#xD;
&#xD;
          3. Any known chronic diseases&#xD;
&#xD;
          4. 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;
          5. Diagnosed food allergy.&#xD;
&#xD;
          6. Pregnancy (urine test during screening&#xD;
&#xD;
          7. Lactation.&#xD;
&#xD;
          8. History of cancer within the past year, from self-report by the woman or as obtained&#xD;
             from her health passport&#xD;
&#xD;
          9. Any medication or supplement which may impact erythrocytes, Hb or haematocrit (to the&#xD;
             opinion of the investigator).&#xD;
&#xD;
         10. Iron supplementation therapy or perfusion in the last three months&#xD;
&#xD;
         11. Significant blood losses over the past 6 months (i.e. trauma, major surgery, blood&#xD;
             donation or other cause influencing blood volume to be investigated by the PI)&#xD;
&#xD;
         12. Have a high alcohol consumption (more than 2 drinks/day).&#xD;
&#xD;
         13. Consumption of illicit drugs based on reported use (based on anamnesis only).&#xD;
&#xD;
         14. Subject having a hierarchical link with the investigator or co-investigators.&#xD;
&#xD;
         15. Fever (body temperature &gt;37.5 °C), on day 1 of the feeding scheme&#xD;
&#xD;
         16. Subject who cannot be expected to comply with treatment (malaria or helminths) or&#xD;
             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. Enrolment in any (micronutrient) food program&#xD;
&#xD;
         19. 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>
    <gender_based>Yes</gender_based>
    <gender_description>Based on health passport or birth certificate.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Zimmermann, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Federal Institute of Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Training and Research Unit of Excellence, University of Malawi</name>
      <address>
        <city>Zomba</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swiss Federal Institute of Technology, Laboratory of Human Nutrition</name>
      <address>
        <city>Zürich</city>
        <state>ZH</state>
        <zip>8092</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biofortification</keyword>
  <keyword>Orange fleshed sweet potato</keyword>
  <keyword>Stable isotope studies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_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/NCT03840031
org study id: SASHA-II
nct id: NCT03840031
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based
      solutions have to be implemented to serve populations, not only individuals. One solution is
      the introduction of iron biofortified staple crops on market level. Before market level
      introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato
      (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and
      total iron absorption after extrinsic stable isotope labelling of the new biofortified high
      iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian
      women of reproductive age with marginal iron status.
The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron
      sweet potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the
      test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57
      for a period of 10 days. The order of test meal type is random. A baseline blood sample will
      be taken on the first meal feeding day prior to consumption of any test meals, on study day
      26 (14 days after completion of the first test meal period) and on Day 40 (14 days after
      completion of the second test meal period). Erythrocyte incorporation of the stable isotope
      labels will be measured in these blood samples using an ICPMS and will be used to calculate
      fractional and total iron absorption from the two different type of test meals.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each woman consumes both Orange Fleshed Sweet Potato varieties
primary purpose: Prevention
masking: Single (Participant)
masking description: Participant is blinded, meal option A --> B or B --> A based on investigator randomisation.
measure: Fractional iron absorption from both Orange Fleshed Sweet Potato varieties
time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
description: Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period
measure: Total iron absorption from both Orange Fleshed Sweet Potato varieties
time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
description: Amount of iron absorbed (mg) from the labelled test meals
measure: Concentration of plasma ferritin level
time frame: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
description: Iron status marker
measure: Concentration of plasma CRP level
time frame: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
description: Inflammation status marker
arm group label: Orange Fleshed Sweet Potato High Iron
arm group type: Experimental
description: Meal sequence B, OFSP High Fe
arm group label: Orange Fleshed Sweet Potato Control
arm group type: Active Comparator
description: Meal sequence A, OFSP control
intervention type: Other
intervention name: High Fe OFSP meal labelled with Fe-58
description: 400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
arm group label: Orange Fleshed Sweet Potato High Iron
intervention type: Other
intervention name: Control OFSP meal labelled with Fe-57
description: 400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
arm group label: Orange Fleshed Sweet Potato Control
criteria: 
gender: Female
gender based: Yes
gender description: Based on health passport or birth certificate.
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Zimmermann, Prof.
role: Principal Investigator
affiliation: Swiss Federal Institute of Technology
facility: 
facility: 
country: Malawi
country: Switzerland
responsible party type: Sponsor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No