<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/NCT02208609</url>
  </required_header>
  <id_info>
    <org_study_id>13-0282</org_study_id>
    <nct_id>NCT02208609</nct_id>
  </id_info>
  <brief_title>Zinc Bioavailability From Amaranth-enriched Maize Tortillas</brief_title>
  <official_title>Absorption of Zinc (Zn) From Traditional Maize Tortillas and Amaranth-enriched Tortillas by Toddlers in the Indigenous Post-Mayan Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Atomic Energy Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Francisco Marroquín</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>
      Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets&#xD;
      and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.&#xD;
      Supplementation of Zn to children during diarrhea episodes has been shown to diminish&#xD;
      duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this&#xD;
      diet might play a role in these processes. Supplementation of this micronutrient in the diet&#xD;
      might be beneficial. The investigators will compare absorption of Zn from white maize&#xD;
      tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool&#xD;
      children in Guatemala.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized cross-over study of zinc absorption in young children living in the&#xD;
      Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and&#xD;
      maize tortillas fortified with 20% amaranth as the major food staple which provides at least&#xD;
      70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as&#xD;
      to which type of tortilla they receive on the first and second day. Fractional absorption of&#xD;
      zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will&#xD;
      be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a&#xD;
      dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally&#xD;
      versus intravenously administered zinc stable isotopes. Measurement of total zinc in&#xD;
      duplicate diets on test days allow for determination of quantities of this micronutrient&#xD;
      absorbed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Zinc Absorption</measure>
    <time_frame>2 days</time_frame>
    <description>Absorption of zinc will be compared in young children when fed the common maize tortilla and a tortilla fortified with 20 % amaranth.. Fractional absorption of zinc for a 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>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Nutritional Deficiency</condition>
  <arm_group>
    <arm_group_label>Maize Tortillas with 20% Amaranth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this arm were fed maize tortillas fortified with 20% amaranth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maize Tortillas without 20% Amaranth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in this arm were fed maize tortillas without amaranth</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Day 1: Maize Tortillas with 20% Amaranth</intervention_name>
    <description>Subjects received Maize tortillas with 20% Amaranth added.</description>
    <arm_group_label>Maize Tortillas with 20% Amaranth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Day 2 Maize Tortillas without 20% Amaranth</intervention_name>
    <description>Maize tortillas without Amaranth.</description>
    <arm_group_label>Maize Tortillas without 20% Amaranth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2-3 years of age&#xD;
&#xD;
          -  apparently healthy&#xD;
&#xD;
          -  eats &gt;2-3 tortillas at each meal of the day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chispitas or macrovital supplementation&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  birth weight &lt; 2,500 g&#xD;
&#xD;
          -  birth defect affecting growth and development&#xD;
&#xD;
          -  chronic infection&#xD;
&#xD;
          -  twin or triplet&#xD;
&#xD;
          -  sibling enrolled in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>Universidad Francisco Marroquin</name>
      <address>
        <city>Guatemala City</city>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guatemala</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Zinc Absorption</keyword>
  <keyword>Maize</keyword>
  <keyword>Amaranth</keyword>
  <keyword>Guatemala</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>
  <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/NCT02208609
org study id: 13-0282
nct id: NCT02208609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets
      and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common.
      Supplementation of Zn to children during diarrhea episodes has been shown to diminish
      duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this
      diet might play a role in these processes. Supplementation of this micronutrient in the diet
      might be beneficial. The investigators will compare absorption of Zn from white maize
      tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool
      children in Guatemala.
This is a randomized cross-over study of zinc absorption in young children living in the
      Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and
      maize tortillas fortified with 20% amaranth as the major food staple which provides at least
      70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as
      to which type of tortilla they receive on the first and second day. Fractional absorption of
      zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will
      be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a
      dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally
      versus intravenously administered zinc stable isotopes. Measurement of total zinc in
      duplicate diets on test days allow for determination of quantities of this micronutrient
      absorbed.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Outcomes Assessor)
measure: Zinc Absorption
time frame: 2 days
description: Absorption of zinc will be compared in young children when fed the common maize tortilla and a tortilla fortified with 20 % amaranth.. Fractional absorption of zinc for a 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: Maize Tortillas with 20% Amaranth
arm group type: Experimental
description: Children in this arm were fed maize tortillas fortified with 20% amaranth
arm group label: Maize Tortillas without 20% Amaranth
arm group type: Experimental
description: Children in this arm were fed maize tortillas without amaranth
intervention type: Other
intervention name: Day 1: Maize Tortillas with 20% Amaranth
description: Subjects received Maize tortillas with 20% Amaranth added.
arm group label: Maize Tortillas with 20% Amaranth
intervention type: Other
intervention name: Day 2 Maize Tortillas without 20% Amaranth
description: Maize tortillas without Amaranth.
arm group label: Maize Tortillas without 20% Amaranth
criteria: 
gender: All
minimum age: 18 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: Guatemala
country: United States
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No