<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/NCT02979080</url>
  </required_header>
  <id_info>
    <org_study_id>Fe_LTL_Be</org_study_id>
    <nct_id>NCT02979080</nct_id>
  </id_info>
  <brief_title>Iron Long-Term Labelling Study Benin</brief_title>
  <official_title>The Evaluation of Iron Supplementation and Iron Requirements Using a Novel Isotope Dilution Method in Beninese 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 in sub-Saharan Africa, a region with a&#xD;
      high prevalence of iron deficiency, making the assessment of iron balance and efficiency of&#xD;
      iron intervention difficult. A potential reference method to quantify iron absorption and&#xD;
      requirements using isotope dilution measurements in women living in areas with high burden of&#xD;
      infection should be developed and validated within this project. The new method will allow&#xD;
      accurate measurement of long term oral iron absorption and the estimation of iron&#xD;
      requirements, potentially providing fundamental guidance for supplementation and&#xD;
      fortification programs in sub-Saharan Africa. In a case series with four months' preventative&#xD;
      iron supplementation intervention imbedded between a four months' control period prior&#xD;
      intervention and a four months' control period after intervention, we will follow a group of&#xD;
      63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate&#xD;
      tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120,&#xD;
      150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron&#xD;
      status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of&#xD;
      soil transmitted helminths and gut inflammation. This design will allow the measurement of&#xD;
      the isotopic iron dilution to assess the total oral iron absorption during the intervention&#xD;
      period in comparison with the control periods without the administration of additional iron&#xD;
      isotopes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 10, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>iron isotope composition in blood</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Iron Absorption</condition>
  <arm_group>
    <arm_group_label>Oral Iron Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eisensulfat LOMAPHARM 50 mg administration for 120 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eisensulfat LOMAPHARM 50 mg</intervention_name>
    <description>Eisensulfat LOMAPHARM 50 mg administration for 120 days</description>
    <arm_group_label>Oral Iron Supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Have participated in one of the original absorption studies&#xD;
&#xD;
          -  Signed written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Long-term medication [except contraceptives]&#xD;
&#xD;
          -  Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes,&#xD;
             hepatitis, hypertension, cancer or cardiovascular diseases according to the&#xD;
             participants own statement or examination of study doctor&#xD;
&#xD;
          -  Blood losses [surgery, accident], donations or transfusions during the past 4 months&#xD;
             before study start.&#xD;
&#xD;
          -  Residence too far away [1 hour or more by motorbike] from study locations; Natitingou&#xD;
             or Cotonou&#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>Hôpital de zone de Natitingou</name>
      <address>
        <city>Natitingou</city>
        <state>Atacora</state>
        <country>Benin</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de zone d'Abomey-Calavi-Sô-Ava</name>
      <address>
        <city>Abomey-Calavi</city>
        <state>Calavi</state>
        <country>Benin</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Benin</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>
  <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/NCT02979080
org study id: Fe_LTL_Be
nct id: NCT02979080
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 in sub-Saharan Africa, a region with a
      high prevalence of iron deficiency, making the assessment of iron balance and efficiency of
      iron intervention difficult. A potential reference method to quantify iron absorption and
      requirements using isotope dilution measurements in women living in areas with high burden of
      infection should be developed and validated within this project. The new method will allow
      accurate measurement of long term oral iron absorption and the estimation of iron
      requirements, potentially providing fundamental guidance for supplementation and
      fortification programs in sub-Saharan Africa. In a case series with four months' preventative
      iron supplementation intervention imbedded between a four months' control period prior
      intervention and a four months' control period after intervention, we will follow a group of
      63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate
      tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120,
      150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron
      status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of
      soil transmitted helminths and gut inflammation. This design will allow the measurement of
      the isotopic iron dilution to assess the total oral iron absorption during the intervention
      period in comparison with the control periods without the administration of additional iron
      isotopes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: iron isotope composition in blood
time frame: 1 year
arm group label: Oral Iron Supplementation
arm group type: Experimental
description: Eisensulfat LOMAPHARM 50 mg administration for 120 days
intervention type: Other
intervention name: Eisensulfat LOMAPHARM 50 mg
description: Eisensulfat LOMAPHARM 50 mg administration for 120 days
arm group label: Oral Iron Supplementation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Benin
responsible party type: Sponsor-Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Prof. Michael B. Zimmermann
investigator title: Professor
sharing ipd: No