<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/NCT03754543</url>
  </required_header>
  <id_info>
    <org_study_id>18.05.INF</org_study_id>
    <nct_id>NCT03754543</nct_id>
  </id_info>
  <brief_title>Baby Iron Bioavailability Study</brief_title>
  <official_title>Iron Bioavailability From Fortified Cereal in Malawian Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kamuzu University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</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>
      The overall objective of this trial is to investigate the iron bioavailability from new&#xD;
      infant cereals in Malawian infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 30 infants aged 6 to 14 months old, the investigator will administer in random order over&#xD;
      2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals)&#xD;
      or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator&#xD;
      will collect one blood sample at baseline and another sample at the end of each phase, thus 3&#xD;
      samples total. In these samples, fractional iron absorption and markers of iron and&#xD;
      inflammation status will be measured . In addition, infant and child acceptability of one of&#xD;
      the infant cereals will be assessed by using a questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 12, 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).</measure>
    <time_frame>up to 6 weeks</time_frame>
    <description>Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe, 57Fe and 58Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated as described above for the primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cereal acceptability questionnaire</measure>
    <time_frame>up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP &lt; 10 mg/L) asymptomatic infection / inflammation.</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard reporting of adverse events (AEs) for safety assessment</measure>
    <time_frame>time of consent to 24 hours after final blood draw</time_frame>
    <description>Reported AEs will include type, incidence, severity, seriousness and relation to intervention. All concomitant medications used to treat illnesses and other conditions will be recorded (both dose and duration).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Iron Bioavailability</condition>
  <arm_group>
    <arm_group_label>Testmeal A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A new, whole-grain infant cereal fortified with ferrous fumarate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testmeal B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testmeal C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>An existing, refined grain infant cereal fortified with ferrous fumarate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testmeal D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An existing, whole-grain infant cereal fortified with ferrous fumarate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testmeal E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An existing, whole-grain infant cereal fortified with ferrous bisglycinate</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe54</intervention_name>
    <description>Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving</description>
    <arm_group_label>Testmeal A</arm_group_label>
    <arm_group_label>Testmeal C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe57</intervention_name>
    <description>Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving</description>
    <arm_group_label>Testmeal B</arm_group_label>
    <arm_group_label>Testmeal D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Labeled iron salt Fe58</intervention_name>
    <description>Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving</description>
    <arm_group_label>Testmeal E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infant age 6 - 14 months&#xD;
&#xD;
          2. Infant exhibits no clinical signs / symptoms of chronic disease or acute illness&#xD;
&#xD;
          3. Capillary haemoglobin concentration &gt; 70g/L&#xD;
&#xD;
          4. Z-scores for weight-for-age and weight-for-length &gt; -2&#xD;
&#xD;
          5. Infant's parent(s) / legally acceptable representative is of legal age of consent, has&#xD;
             anticipated residence in the area for the duration of the study, and is willing and&#xD;
             able to fulfil the requirements of the study protocol&#xD;
&#xD;
          6. Infant is expected to consume the entire 25 g portion during infant cereal feeding&#xD;
             based on the Investigator's judgement established via observations of feeding during&#xD;
             the adaptation phase&#xD;
&#xD;
          7. Infant received a complete dose of intermittent preventive treatment with&#xD;
             dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth&#xD;
             treatment with Albendazole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parents not willing / not able to comply with the requirements of study protocol&#xD;
&#xD;
          2. Infants receiving iron-containing supplements in the 2 months prior to enrollment&#xD;
             (other supplements are acceptable)&#xD;
&#xD;
          3. Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in&#xD;
             the test cereals (e.g., celiac disease)&#xD;
&#xD;
          4. Infants participating in any other clinical trial prior to enrollment&#xD;
&#xD;
          5. Infants or infant's family who in the Investigator's judgment cannot be expected to&#xD;
             comply with the protocol or study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>14 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamija Phiri, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kamuzu University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Hospital</name>
      <address>
        <city>Zomba</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 4, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
  </intervention_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/NCT03754543
org study id: 18.05.INF
nct id: NCT03754543
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this trial is to investigate the iron bioavailability from new
      infant cereals in Malawian infants.
In 30 infants aged 6 to 14 months old, the investigator will administer in random order over
      2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals)
      or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator
      will collect one blood sample at baseline and another sample at the end of each phase, thus 3
      samples total. In these samples, fractional iron absorption and markers of iron and
      inflammation status will be measured . In addition, infant and child acceptability of one of
      the infant cereals will be assessed by using a questionnaire.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
time frame: up to 6 weeks
description: Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic
measure: Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).
time frame: up to 6 weeks
description: Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe, 57Fe and 58Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated as described above for the primary endpoint
measure: Cereal acceptability questionnaire
time frame: up to 2 weeks
measure: Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.
time frame: up to 6 weeks
measure: Standard reporting of adverse events (AEs) for safety assessment
time frame: time of consent to 24 hours after final blood draw
description: Reported AEs will include type, incidence, severity, seriousness and relation to intervention. All concomitant medications used to treat illnesses and other conditions will be recorded (both dose and duration).
arm group label: Testmeal A
arm group type: Active Comparator
description: A new, whole-grain infant cereal fortified with ferrous fumarate
arm group label: Testmeal B
arm group type: Active Comparator
description: An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate
arm group label: Testmeal C
arm group type: Placebo Comparator
description: An existing, refined grain infant cereal fortified with ferrous fumarate
arm group label: Testmeal D
arm group type: Active Comparator
description: An existing, whole-grain infant cereal fortified with ferrous fumarate
arm group label: Testmeal E
arm group type: Active Comparator
description: An existing, whole-grain infant cereal fortified with ferrous bisglycinate
intervention type: Other
intervention name: Labeled iron salt Fe54
description: Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
arm group label: Testmeal A
arm group label: Testmeal C
intervention type: Other
intervention name: Labeled iron salt Fe57
description: Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
arm group label: Testmeal B
arm group label: Testmeal D
intervention type: Other
intervention name: Labeled iron salt Fe58
description: Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
arm group label: Testmeal E
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Kamija Phiri, Prof.
role: Principal Investigator
affiliation: Kamuzu University of Health Sciences
facility: 
country: Malawi
responsible party type: Sponsor
mesh term: Iron
sharing ipd: No