<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/NCT02989311</url>
  </required_header>
  <id_info>
    <org_study_id>FeGOS_Hepcidin</org_study_id>
    <nct_id>NCT02989311</nct_id>
  </id_info>
  <brief_title>Effect of Timing of Micronutrient Powder Consumption on Iron Absorption in Infants</brief_title>
  <official_title>Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jomo Kenyatta University of Agriculture and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Msambweni County Referral Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia&#xD;
      (IDA), which adversely affects their growth and cognitive development. In-home iron&#xD;
      fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA&#xD;
      by ensuring that the iron needs of infants and young children are met without changing their&#xD;
      traditional diet. In order to optimize iron absorption timing of MNP consumption might as&#xD;
      well be important. This is because hepcidin, a key regulator of systemic iron balance, shows&#xD;
      a circadian increase that may influence morning versus afternoon iron absorption from the&#xD;
      MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit&#xD;
      iron absorption from a second dose, consumed close in time to the first dose.&#xD;
&#xD;
      To determine the difference between i) morning versus afternoon iron absorption and ii)&#xD;
      consecutive versus alternate day iron absorption, investigators will enrol 20 infants from&#xD;
      Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2&#xD;
      test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in&#xD;
      the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting&#xD;
      of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days&#xD;
      and 1 alternate day. In both studies, fourteen days after the last test meal administration,&#xD;
      a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and&#xD;
      inflammation status parameter will be determined at baseline and endpoint. Hepcidin&#xD;
      concentrations will be measured before the morning and afternoon meals (study 1) and after&#xD;
      second consecutive meal (study 2).&#xD;
&#xD;
      Knowing the effect of time on the expected iron absorption will inform decisions on the ideal&#xD;
      timing of MNP to cover the infant's requirement for absorbed iron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 infants will be recruited from the Msambweni County Referral Hospital in southern coastal&#xD;
      Kenya to participate in both studies.&#xD;
&#xD;
      Study 1:&#xD;
&#xD;
      At baseline a morning blood sample will be collected from potential study participants for&#xD;
      the determination of the following iron and inflammation status parameters: hemoglobin (Hb),&#xD;
      hepcidin, plasma ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin&#xD;
      (ZnPP), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height,&#xD;
      weight, mid-upper arm and head circumference) will be measured, and demographics, the medical&#xD;
      history and the feeding habits will be assessed using a questionnaire.&#xD;
&#xD;
      Infants will consume the 1st test meal the next day after enrolment in the morning (day1). On&#xD;
      day 2 a 2nd blood sample (1ml) will be collected in the afternoon quantify afternoon&#xD;
      concentration of hepcidin in plasma and then the infants will consume the 2nd meal on the 3rd&#xD;
      day in the afternoon.&#xD;
&#xD;
      The two isotopically labelled test meals will be fed to the infants by their caregivers under&#xD;
      supervision of the research team. The morning test meal A will contain 12 mg of iron as&#xD;
      ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. The afternoon test meal will contain&#xD;
      12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10 mg of 56Fe.&#xD;
&#xD;
      The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml) and&#xD;
      will be randomly administered on the two alternate days (AB or BA). Overnight, only breast&#xD;
      milk will be allowed to the infant before coming for the morning meal and no breast milk will&#xD;
      be given at least 3 h before both morning and afternoon test meal administration. Infants&#xD;
      will not be allowed to eat or drink for 2 h after the test meal. Fourteen days after the&#xD;
      second test meal administration, 3 ml of whole blood will be collected by venipuncture for&#xD;
      iron isotopic analysis and iron and inflammation status. Anthropometrics and health status&#xD;
      will be assessed.&#xD;
&#xD;
      Study 2:&#xD;
&#xD;
      At baseline a blood sample will be collected from potential study participants for the&#xD;
      determination of iron and inflammation status parameters: hemoglobin (Hb), hepcidin, plasma&#xD;
      ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin (ZnPP), C-reactive&#xD;
      protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height, weight, mid-upper&#xD;
      arm and head circumference) will be measured, and demographics, the medical history and the&#xD;
      feeding habits will be assessed using a questionnaire.&#xD;
&#xD;
      Infants will be randomized to consume the consecutive days or alternate day meal schedule on&#xD;
      day 1. 1ml of blood will be collected after the second consecutive meal to determine hepcidin&#xD;
      level.&#xD;
&#xD;
      Test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 54Fe and 10mg of&#xD;
      56Fe. Test meal B will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and&#xD;
      10mg of 56Fe. Test meal C will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe&#xD;
      and 10mg of 56Fe. All test meals will be consumed in the morning.&#xD;
&#xD;
      The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml).&#xD;
      Overnight, only breast milk will be allowed to the infant and no breast milk will be given at&#xD;
      least 3 h before test meal administration. Test meals plus mineral water will be consumed&#xD;
      completely in the presence of the investigators, and the infant will not be allowed to eat or&#xD;
      drink for 2 h after the test meal. Fourteen days after the third test meal, 3 ml of whole&#xD;
      blood will be collected by venipuncture for iron and inflammation status, and iron analysis&#xD;
      in red blood cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively</measure>
    <time_frame>Baseline and day 18, baseline and day 19</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hepcidin concentration</measure>
    <time_frame>Baseline and day 3, and day 2 for study 1 and 2 respectively</time_frame>
    <description>We will measure hepcidin concentration in the morning and in the afternoon and then after consumption of a 2nd consecutive test meal in Study 1 and 2 respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Iron status</measure>
    <time_frame>Baseline and days 18 and 19 for study 1 and 2 respectively</time_frame>
    <description>We will assess haemoglobin, plasma ferritin and soluble transferrin receptor to define the iron status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation status</measure>
    <time_frame>Baseline and days 18 and 19 for study 1 and 2 respectively</time_frame>
    <description>We will assess C-reactive protein and alpha acid glycoprotein to assess systemic inflammatory status</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Anemia</condition>
  <condition>Iron Deficiency</condition>
  <arm_group>
    <arm_group_label>Study 1:Morning test meal+Iron+MNP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe.&#xD;
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 1:Afternoon test meal+Iron+MNP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe.&#xD;
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 2: Consecutive meals+Iron+MNP+GOS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe.&#xD;
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study 2:Alternate meal+Iron+MNP+GOS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meal C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg.&#xD;
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortified maize porridge (MNP and Iron)</intervention_name>
    <description>Maize porridge fortified with MNP and labelled iron compound</description>
    <arm_group_label>Study 1:Afternoon test meal+Iron+MNP</arm_group_label>
    <arm_group_label>Study 1:Morning test meal+Iron+MNP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortified Maize porridge (MNP + Iron + GOS)</intervention_name>
    <description>Maize porridge fortified with MNP + GOS and labelled iron compound</description>
    <arm_group_label>Study 2: Consecutive meals+Iron+MNP+GOS</arm_group_label>
    <arm_group_label>Study 2:Alternate meal+Iron+MNP+GOS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 6-14 months at baseline&#xD;
&#xD;
          -  Assessment of good health as assessed by health professional staff at Msambweni County&#xD;
             Referral Hospital&#xD;
&#xD;
          -  Willingness of their caregiver to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin &lt;70 g/L; these infants will be referred for treatment according to local&#xD;
             standard of care&#xD;
&#xD;
          -  Severe underweight (Z-score weight-for-age &lt;-3) and /or severe wasting (Z-score&#xD;
             weight-for-height&lt;-3)&#xD;
&#xD;
          -  Chronic or acute illness or other conditions that in the opinion of the Principle&#xD;
             Investigator (PI) or co-researchers would jeopardize the safety or rights of a&#xD;
             participant in the trial or would render the participant unable to comply with the&#xD;
             protocol&#xD;
&#xD;
          -  Participants taking part in other studies requiring the drawing of blood&#xD;
&#xD;
          -  Participants who are taking iron-containing food supplements or tablets/drops&#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>Michael Zimmermann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Federal Institute of Technology (ETH), Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Msambweni County Referral Hospital</name>
      <address>
        <city>Msambweni</city>
        <state>Kwale County</state>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iron absorption</keyword>
  <keyword>Iron deficiency</keyword>
  <keyword>Hepcidin</keyword>
  <keyword>Stable isotopes</keyword>
  <keyword>Anemia</keyword>
  <keyword>Infants</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be published in a peer-review journal</ipd_description>
  </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/NCT02989311
org study id: FeGOS_Hepcidin
nct id: NCT02989311
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Infants and young children in sub-Saharan Africa have high rates of iron deficiency anemia
      (IDA), which adversely affects their growth and cognitive development. In-home iron
      fortification of complementary foods using micronutrient powders (MNPs) reduces risk for IDA
      by ensuring that the iron needs of infants and young children are met without changing their
      traditional diet. In order to optimize iron absorption timing of MNP consumption might as
      well be important. This is because hepcidin, a key regulator of systemic iron balance, shows
      a circadian increase that may influence morning versus afternoon iron absorption from the
      MNP. Furthermore, a single dose of iron can increase hepcidin levels and potentially inhibit
      iron absorption from a second dose, consumed close in time to the first dose.

      To determine the difference between i) morning versus afternoon iron absorption and ii)
      consecutive versus alternate day iron absorption, investigators will enrol 20 infants from
      Kwale County aged 6-14 months and conduct two studies. In study 1, infants will consume 2
      test meals consisting of maize porridge containing isotopically labelled Ferrous Sulphate in
      the morning and afternoon on 2 days. In study 2, infants will consume 3 test meals consisting
      of maize porridge containing isotopically labelled Ferrous Sulphate on two consecutive days
      and 1 alternate day. In both studies, fourteen days after the last test meal administration,
      a whole blood sample will be collected by venipuncture for iron isotopic analysis. Iron and
      inflammation status parameter will be determined at baseline and endpoint. Hepcidin
      concentrations will be measured before the morning and afternoon meals (study 1) and after
      second consecutive meal (study 2).

      Knowing the effect of time on the expected iron absorption will inform decisions on the ideal
      timing of MNP to cover the infant's requirement for absorbed iron.
20 infants will be recruited from the Msambweni County Referral Hospital in southern coastal
      Kenya to participate in both studies.

      Study 1:

      At baseline a morning blood sample will be collected from potential study participants for
      the determination of the following iron and inflammation status parameters: hemoglobin (Hb),
      hepcidin, plasma ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin
      (ZnPP), C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height,
      weight, mid-upper arm and head circumference) will be measured, and demographics, the medical
      history and the feeding habits will be assessed using a questionnaire.

      Infants will consume the 1st test meal the next day after enrolment in the morning (day1). On
      day 2 a 2nd blood sample (1ml) will be collected in the afternoon quantify afternoon
      concentration of hepcidin in plasma and then the infants will consume the 2nd meal on the 3rd
      day in the afternoon.

      The two isotopically labelled test meals will be fed to the infants by their caregivers under
      supervision of the research team. The morning test meal A will contain 12 mg of iron as
      ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe. The afternoon test meal will contain
      12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10 mg of 56Fe.

      The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml) and
      will be randomly administered on the two alternate days (AB or BA). Overnight, only breast
      milk will be allowed to the infant before coming for the morning meal and no breast milk will
      be given at least 3 h before both morning and afternoon test meal administration. Infants
      will not be allowed to eat or drink for 2 h after the test meal. Fourteen days after the
      second test meal administration, 3 ml of whole blood will be collected by venipuncture for
      iron isotopic analysis and iron and inflammation status. Anthropometrics and health status
      will be assessed.

      Study 2:

      At baseline a blood sample will be collected from potential study participants for the
      determination of iron and inflammation status parameters: hemoglobin (Hb), hepcidin, plasma
      ferritin (PF), soluble transferrin receptor (sTfR), zinc protoporphyrin (ZnPP), C-reactive
      protein (CRP), alpha-1-acid glycoprotein (AGP). Anthropometrics (height, weight, mid-upper
      arm and head circumference) will be measured, and demographics, the medical history and the
      feeding habits will be assessed using a questionnaire.

      Infants will be randomized to consume the consecutive days or alternate day meal schedule on
      day 1. 1ml of blood will be collected after the second consecutive meal to determine hepcidin
      level.

      Test meal A will contain 12 mg of iron as ferrous sulfate given as 2 mg of 54Fe and 10mg of
      56Fe. Test meal B will contain 12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and
      10mg of 56Fe. Test meal C will contain 12 mg of iron as ferrous sulfate given as 2 mg of 58Fe
      and 10mg of 56Fe. All test meals will be consumed in the morning.

      The test meals will consist of maize porridge (5-10% dry weight) and mineral water (8ml).
      Overnight, only breast milk will be allowed to the infant and no breast milk will be given at
      least 3 h before test meal administration. Test meals plus mineral water will be consumed
      completely in the presence of the investigators, and the infant will not be allowed to eat or
      drink for 2 h after the test meal. Fourteen days after the third test meal, 3 ml of whole
      blood will be collected by venipuncture for iron and inflammation status, and iron analysis
      in red blood cells.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change from baseline in isotopic ratio of iron in blood at day 18 and 19 for Study 1 and 2 respectively
time frame: Baseline and day 18, baseline and day 19
measure: Hepcidin concentration
time frame: Baseline and day 3, and day 2 for study 1 and 2 respectively
description: We will measure hepcidin concentration in the morning and in the afternoon and then after consumption of a 2nd consecutive test meal in Study 1 and 2 respectively
measure: Iron status
time frame: Baseline and days 18 and 19 for study 1 and 2 respectively
description: We will assess haemoglobin, plasma ferritin and soluble transferrin receptor to define the iron status.
measure: Inflammation status
time frame: Baseline and days 18 and 19 for study 1 and 2 respectively
description: We will assess C-reactive protein and alpha acid glycoprotein to assess systemic inflammatory status
arm group label: Study 1:Morning test meal+Iron+MNP
arm group type: Active Comparator
description: The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the morning test meal A:12 mg of iron as ferrous sulfate given as 2 mg of 57Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)
arm group label: Study 1:Afternoon test meal+Iron+MNP
arm group type: Active Comparator
description: The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, maltodextrin carrier (added up to 11g). Iron compound added to the afternoon test meal B:12 mg of iron as ferrous sulfate given as 2 mg of 58Fe and 10mg of 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP + Iron)
arm group label: Study 2: Consecutive meals+Iron+MNP+GOS
arm group type: Active Comparator
description: The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous Fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meals:Test meal A will contain 12mg of ferrous sulphate given as 2mg 54Fe and 10mg 56Fe. Test meal B will contain 12mg of ferrous sulphate given as 2mg 57Fe and 10mg 56Fe.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)
arm group label: Study 2:Alternate meal+Iron+MNP+GOS
arm group type: Active Comparator
description: The MNP contains 400 μg Vitamin A, 5 μg Vitamin D, 5 mg Tocopherol Equivalent, 0.5 mg Thiamine, 0.5 mg Riboflavin, 0.5 mg Vitamin B6 , 90 μg Folic Acid,6 mg Niacin, 0.9 μg Vitamin B12, 30 mg Vitamin C, 0.56 mg Copper, 90 μg, Iodine, 17 μg Selenium, 4.1 mg Zinc, 190 Phytase-units, plus 2.5 mg Fe as Ferrous fumarate and 2.5 mg Fe as NaFeEDTA, plus 7.5 g of galacto-oligosaccharides given as 10.5 g GOS-75, maltodextrin carrier (added up to 11g) Iron compound added to the test meal C: 12mg of ferrous sulphate given as 2mg 58Fe and 10mg.
Intervention: Dietary supplement: Fortified maize porridge (MNP+ Iron + GOS)
intervention type: Dietary Supplement
intervention name: Fortified maize porridge (MNP and Iron)
description: Maize porridge fortified with MNP and labelled iron compound
arm group label: Study 1:Afternoon test meal+Iron+MNP
arm group label: Study 1:Morning test meal+Iron+MNP
intervention type: Dietary Supplement
intervention name: Fortified Maize porridge (MNP + Iron + GOS)
description: Maize porridge fortified with MNP + GOS and labelled iron compound
arm group label: Study 2: Consecutive meals+Iron+MNP+GOS
arm group label: Study 2:Alternate meal+Iron+MNP+GOS
criteria: 
gender: All
minimum age: 6 Months
maximum age: 14 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Zimmermann, MD
role: Principal Investigator
affiliation: Swiss Federal Institute of Technology (ETH), Zurich
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Iron
sharing ipd: Yes
ipd description: Data will be published in a peer-review journal