<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/NCT02208635</url>
  </required_header>
  <id_info>
    <org_study_id>14-1126</org_study_id>
    <nct_id>NCT02208635</nct_id>
  </id_info>
  <brief_title>Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months</brief_title>
  <acronym>HPZM</acronym>
  <official_title>Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Teaching Hospital, Lusaka, Zambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HarvestPlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the quantity of Zn absorbed from an accurately&#xD;
      weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from&#xD;
      biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified&#xD;
      (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual&#xD;
      food staple is maize.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participating children were randomized to receive an accurately weighed quantity of ~100g/day&#xD;
      of either the control, fortified or biofortified study maize for 1 day.&#xD;
&#xD;
      On day 1, mothers brought their child to the health center before breakfast. All meals were&#xD;
      extrinsically labeled with a zinc stable isotope (70Zn). Meals on this day were consumed in&#xD;
      the presence of the research staff. The quantities of nshima or porridge prepared and eaten&#xD;
      were accurately weighed and duplicate meals were collected for subsequent mineral analyses.&#xD;
&#xD;
      Between lunch and dinner on day 1 at the Health Center, a blood sample was collected for Hb&#xD;
      and plasma Zn analyses and, immediately after and through the same needle, a stable isotope&#xD;
      of zinc was intravenously administered into a forearm vein over 1-2 minutes. The family then&#xD;
      returned home.&#xD;
&#xD;
      Morning spot urine samples were collected twice daily starting on day 5 and continuing&#xD;
      through day 8. Once these collections were finished, the study for this child was complete.&#xD;
&#xD;
      Dietary Zn was measured from laboratory assays of the duplicate test meals. Fractional&#xD;
      absorption of Zn (FAZ) was measured by dual isotope tracer ratio methods in urine. Absorbed&#xD;
      Zn was calculated by multiplying dietary Zn by FAZ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Parallel Assignment</intervention_model>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absorption of zinc</measure>
    <time_frame>1 day</time_frame>
    <description>Absorption of zinc will be measured in young children fed a diet of control, Zn-biofortified, or Zn-fortified maize. Fractional absorption of zinc from all meals of the day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nutritional Deficiency</condition>
  <arm_group>
    <arm_group_label>Biofortified Maize</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm were fed zinc biofortified maize (~30 µg Zn/g).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fortified Maize</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Maize</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biofortified Maize</intervention_name>
    <description>Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).</description>
    <arm_group_label>Biofortified Maize</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fortified Maize</intervention_name>
    <description>Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).</description>
    <arm_group_label>Fortified Maize</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Maize</intervention_name>
    <description>Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).</description>
    <arm_group_label>Control Maize</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children age 24 to 36 months&#xD;
&#xD;
          -  Maize meal accounts for at least 75% energy intake&#xD;
&#xD;
          -  Able to consume 100 g maize flour/day&#xD;
&#xD;
          -  Clinically healthy (stunting is acceptable)&#xD;
&#xD;
          -  Lives in target community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with chronic or other known chronic disease&#xD;
&#xD;
          -  If children are receiving zinc-fortified products, these products will need to be&#xD;
             withheld for 2 weeks prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hambidge, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Teaching Hospital</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
    <country>Zambia</country>
  </location_countries>
  <results_reference>
    <citation>Chomba E, Westcott CM, Westcott JE, Mpabalwani EM, Krebs NF, Patinkin ZW, Palacios N, Hambidge KM. Zinc absorption from biofortified maize meets the requirements of young rural Zambian children. J Nutr. 2015 Mar;145(3):514-9. doi: 10.3945/jn.114.204933. Epub 2015 Jan 21.</citation>
    <PMID>25733467</PMID>
  </results_reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 26, 2016</last_update_submitted>
  <last_update_submitted_qc>April 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Zinc Absorption</keyword>
  <keyword>Biofortification</keyword>
  <keyword>Maize</keyword>
  <keyword>Zambia</keyword>
  <keyword>Stable isotopes of Zn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT02208635
org study id: 14-1126
nct id: NCT02208635
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to compare the quantity of Zn absorbed from an accurately
      weighed quantity (~100 g) of minimally milled control maize (~15 µg Zn/g maize), from
      biofortified maize (~30 µg Zn/g) and from the same control maize that has been fortified
      (total level of ~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual
      food staple is maize.
Participating children were randomized to receive an accurately weighed quantity of ~100g/day
      of either the control, fortified or biofortified study maize for 1 day.

      On day 1, mothers brought their child to the health center before breakfast. All meals were
      extrinsically labeled with a zinc stable isotope (70Zn). Meals on this day were consumed in
      the presence of the research staff. The quantities of nshima or porridge prepared and eaten
      were accurately weighed and duplicate meals were collected for subsequent mineral analyses.

      Between lunch and dinner on day 1 at the Health Center, a blood sample was collected for Hb
      and plasma Zn analyses and, immediately after and through the same needle, a stable isotope
      of zinc was intravenously administered into a forearm vein over 1-2 minutes. The family then
      returned home.

      Morning spot urine samples were collected twice daily starting on day 5 and continuing
      through day 8. Once these collections were finished, the study for this child was complete.

      Dietary Zn was measured from laboratory assays of the duplicate test meals. Fractional
      absorption of Zn (FAZ) was measured by dual isotope tracer ratio methods in urine. Absorbed
      Zn was calculated by multiplying dietary Zn by FAZ.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Absorption of zinc
time frame: 1 day
description: Absorption of zinc will be measured in young children fed a diet of control, Zn-biofortified, or Zn-fortified maize. Fractional absorption of zinc from all meals of the day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
arm group label: Biofortified Maize
arm group type: Experimental
description: Participants in this arm were fed zinc biofortified maize (~30 µg Zn/g).
arm group label: Fortified Maize
arm group type: Experimental
description: Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).
arm group label: Control Maize
arm group type: Active Comparator
description: Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).
intervention type: Other
intervention name: Biofortified Maize
description: Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).
arm group label: Biofortified Maize
intervention type: Other
intervention name: Fortified Maize
description: Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).
arm group label: Fortified Maize
intervention type: Other
intervention name: Control Maize
description: Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).
arm group label: Control Maize
criteria: 
gender: All
minimum age: 24 Months
maximum age: 36 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Hambidge, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
country: United States
country: Zambia
citation: Chomba E, Westcott CM, Westcott JE, Mpabalwani EM, Krebs NF, Patinkin ZW, Palacios N, Hambidge KM. Zinc absorption from biofortified maize meets the requirements of young rural Zambian children. J Nutr. 2015 Mar;145(3):514-9. doi: 10.3945/jn.114.204933. Epub 2015 Jan 21.
PMID: 25733467
responsible party type: Sponsor
mesh term: Malnutrition