<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/NCT02241330</url>
  </required_header>
  <id_info>
    <org_study_id>EK 2013-N-52</org_study_id>
    <nct_id>NCT02241330</nct_id>
  </id_info>
  <brief_title>Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status</brief_title>
  <official_title>Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HarvestPlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Federal Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research is to test the efficacy of Zn biofortified wheat in increasing&#xD;
      Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of plasma zinc values from baseline to endpoint and two months post intervention</measure>
    <time_frame>day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention</time_frame>
    <description>plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>CRP will be measured at baseline, midpoint (random sparse sampling), endpoint (end of intervention) and randomly within two months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>AGP will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months)and randomly within two months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Iron status from baseline to the end of the intervention and 2 months post-intervention</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>Hb will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Iron status from baseline to the end of intervention, and within two months post-intervention</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>Serum ferritin will be measured at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Zn biomarkers</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>new potential zn biomarkers will be measured in whole blood and plasma at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New potential Zn biomarkers in buccal cells</measure>
    <time_frame>day 0, random during the intervention, month 6, and random 2 months post intervention</time_frame>
    <description>MT RNA transcript in buccal cells will be measured at baseline, midpoint (random sparse sampling), endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of gut microflora</measure>
    <time_frame>baseline, endpoint (6 months)</time_frame>
    <description>Characterization of microflora will be done in a subsamples of children (taken randomly), at baseline and at the end of feeding (6 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometry</measure>
    <time_frame>baseline (day 0), endpoint (6 months)</time_frame>
    <description>anthropometry, such as height, weight will be measured at baseline and endpoint of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morbidity</measure>
    <time_frame>throughout the study</time_frame>
    <description>morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">284</enrollment>
  <condition>Zinc Deficiency</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control wheat used for meal, level of zinc is usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fortification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biofortified</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Biofortified wheat</intervention_name>
    <description>Wheat was grown by foliar Zn application and is therefore biofortified</description>
    <arm_group_label>Biofortified</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fortification</intervention_name>
    <description>Wheat flour is fortified before testmeal preparation</description>
    <arm_group_label>fortification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>wheat flour is used as control comparator.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generally healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unhealthy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael B Zimmermann, Prof Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>ETHZ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anura V Kurpad, Prof MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St John's Research Institute, Bangalore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St John's Research Institute</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>460034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://humannutrition.ethz.ch</url>
    <description>Human Nutrition Laboratory ETHZ</description>
  </link>
  <link>
    <url>http://www.harvestplus.org</url>
    <description>HarvestPlus website</description>
  </link>
  <link>
    <url>http://www.sjri.res.in/</url>
    <description>St John's Research Institute website</description>
  </link>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>April 13, 2016</last_update_submitted>
  <last_update_submitted_qc>April 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>Prof</investigator_title>
  </responsible_party>
  <keyword>Zinc</keyword>
  <keyword>deficiency</keyword>
  <keyword>biofortification</keyword>
  <keyword>wheat</keyword>
  <!-- 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/NCT02241330
org study id: EK 2013-N-52
nct id: NCT02241330
lead sponsor: 
collaborator: 
has dmc: No
The objective of this research is to test the efficacy of Zn biofortified wheat in increasing
      Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of plasma zinc values from baseline to endpoint and two months post intervention
time frame: day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention
description: plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention
measure: Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: CRP will be measured at baseline, midpoint (random sparse sampling), endpoint (end of intervention) and randomly within two months post-intervention
measure: Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: AGP will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months)and randomly within two months post-intervention
measure: Change in Iron status from baseline to the end of the intervention and 2 months post-intervention
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: Hb will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention
measure: Change in Iron status from baseline to the end of intervention, and within two months post-intervention
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: Serum ferritin will be measured at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention
measure: New Zn biomarkers
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: new potential zn biomarkers will be measured in whole blood and plasma at baseline, midpoint (random sparse sampling), endpoint and randomly within two months post-intervention
measure: New potential Zn biomarkers in buccal cells
time frame: day 0, random during the intervention, month 6, and random 2 months post intervention
description: MT RNA transcript in buccal cells will be measured at baseline, midpoint (random sparse sampling), endpoint
measure: Characterization of gut microflora
time frame: baseline, endpoint (6 months)
description: Characterization of microflora will be done in a subsamples of children (taken randomly), at baseline and at the end of feeding (6 months)
measure: Anthropometry
time frame: baseline (day 0), endpoint (6 months)
description: anthropometry, such as height, weight will be measured at baseline and endpoint of the study
measure: morbidity
time frame: throughout the study
description: morbidity, mainly diarrhea and pneumonia episodes, will be recorded throughout the study
arm group label: Control
arm group type: Placebo Comparator
description: Control wheat used for meal, level of zinc is usual
arm group label: fortification
arm group type: Active Comparator
description: Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation
arm group label: Biofortified
arm group type: Active Comparator
description: Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control
intervention type: Dietary Supplement
intervention name: Biofortified wheat
description: Wheat was grown by foliar Zn application and is therefore biofortified
arm group label: Biofortified
intervention type: Dietary Supplement
intervention name: Fortification
description: Wheat flour is fortified before testmeal preparation
arm group label: fortification
intervention type: Dietary Supplement
intervention name: Control
description: wheat flour is used as control comparator.
arm group label: Control
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael B Zimmermann, Prof Dr med
role: Principal Investigator
affiliation: ETHZ
last name: Anura V Kurpad, Prof MD PhD
role: Principal Investigator
affiliation: St John's Research Institute, Bangalore
facility: 
country: India
url: http://humannutrition.ethz.ch
description: Human Nutrition Laboratory ETHZ
url: http://www.harvestplus.org
description: HarvestPlus website
url: http://www.sjri.res.in/
description: St John's Research Institute website
responsible party type: Principal Investigator
investigator affiliation: Swiss Federal Institute of Technology
investigator full name: Prof. Michael B. Zimmermann
investigator title: Prof