<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/NCT02977806</url>
  </required_header>
  <id_info>
    <org_study_id>Fe_LTL_Ma</org_study_id>
    <nct_id>NCT02977806</nct_id>
  </id_info>
  <brief_title>Iron Long-Term Labelling Study Malawi</brief_title>
  <official_title>The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study</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>
  </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 new method allowing accurate measurement of long-term oral&#xD;
      iron absorption and allowing the estimation of iron requirements is highly needed. Such a&#xD;
      novel method to quantify iron absorption and requirements using isotope dilution measurements&#xD;
      in children should be validated in the present prospective observational study by&#xD;
      following-up a group of 49 children given a stable iron isotope in an earlier trial. We will&#xD;
      request seven blood samples within 2 years (sampling every four months) from the participants&#xD;
      which will allow us to measure isotopic dilution for estimating total oral iron absorption&#xD;
      over these 24 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>iron isotope composition in blood</measure>
    <time_frame>2 years</time_frame>
    <description>the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days</description>
  </primary_outcome>
  <enrollment type="Actual">48</enrollment>
  <condition>Iron Absorption</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Malawian children who ingested stable iron isotopes in the frame of a former iron&#xD;
        absorption study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have participated in the original absorption study and the two follow-up samplings&#xD;
&#xD;
          -  Signed written informed consent from the guardian to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Long-term medication&#xD;
&#xD;
          -  Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes,&#xD;
             hepatitis, hypertension, cancer or cardiovascular diseases (according to the&#xD;
             guardian's statement or med-ical examination (health booklet))&#xD;
&#xD;
          -  Blood losses (surgery, accident) or blood transfusion during the past 4 months before&#xD;
             study start.&#xD;
&#xD;
          -  Residence too far away (&gt; 2 hours by motorbike) from study location (Zomba)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 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>Human Nutrition Laboratory, ETH Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of Medicine</name>
      <address>
        <city>Blantyre</city>
        <zip>03</zip>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</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/NCT02977806
org study id: Fe_LTL_Ma
nct id: NCT02977806
lead sponsor: 
has dmc: 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 new method allowing accurate measurement of long-term oral
      iron absorption and allowing the estimation of iron requirements is highly needed. Such a
      novel method to quantify iron absorption and requirements using isotope dilution measurements
      in children should be validated in the present prospective observational study by
      following-up a group of 49 children given a stable iron isotope in an earlier trial. We will
      request seven blood samples within 2 years (sampling every four months) from the participants
      which will allow us to measure isotopic dilution for estimating total oral iron absorption
      over these 24 months.
observational model: Cohort
time perspective: Prospective
measure: iron isotope composition in blood
time frame: 2 years
description: the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Zimmermann, Prof.
role: Principal Investigator
affiliation: Human Nutrition Laboratory, ETH Zürich
facility: 
country: Malawi
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