<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/NCT02233764</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #: 1403004556</org_study_id>
    <nct_id>NCT02233764</nct_id>
  </id_info>
  <brief_title>Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India</brief_title>
  <official_title>Effect of Iron- and Zinc-Biofortified Pearl Millet (ICTP8203-Fe) Consumption on Growth and Immunity in Children Aged 12-18 Months in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SNDT Women's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. John's Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for the Study of Social Change</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, iron- and zinc-biofortified pearl millet will be fed to young children in&#xD;
      Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function&#xD;
      in comparison to children receiving non-biofortified pearl millet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron and zinc deficiency remain a major worldwide public health problem, especially in&#xD;
      developing countries such as India. In this randomized study, 700 children aged 12-18 months&#xD;
      from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or&#xD;
      control pearl millet three times per day, six days per week, for nine months. The goal of&#xD;
      this study is to examine the effects of iron and zinc biofortified millet on immune function,&#xD;
      growth, and cognitive function in this age group. The key outcome measures are biomarkers of&#xD;
      iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin,&#xD;
      ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at&#xD;
      an intermediate time point (midline; random serial sampling) and after 9 months of follow-up&#xD;
      (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha&#xD;
      1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To&#xD;
      assess cognitive function in a subset, multiple specific aspects of memory, attention, and&#xD;
      processing speed will be assessed. Higher-level, integrative cognitive abilities that require&#xD;
      the coordination of multiple specific functions, such as problem-solving and exploratory&#xD;
      behavior and global aspects of attention during free play with toys, will also be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Actual">July 16, 2018</completion_date>
  <primary_completion_date type="Actual">July 16, 2018</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Iron status</measure>
    <time_frame>Midline serial assessment/sample between months 2-7</time_frame>
    <description>Determined by serum ferritin, sTfR, and total body iron</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron status</measure>
    <time_frame>Endline (nine months)</time_frame>
    <description>Determined by serum ferritin, sTfR, and total body iron</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical growth</measure>
    <time_frame>Midline serial assessment/sample between months 2-7</time_frame>
    <description>As determined by length/height, weight, head circumference, and mid-upper arm circumference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical growth</measure>
    <time_frame>Endline (nine months)</time_frame>
    <description>As determined by length/height, weight, head circumference, and mid-upper arm circumference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune function</measure>
    <time_frame>1 Midline serial assessment/sample between months 2-7</time_frame>
    <description>Measurement of T cell counts and vaccine response ELISA assays.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune function</measure>
    <time_frame>Endline (nine months)</time_frame>
    <description>Measurement of T cell counts and vaccine response ELISA assays.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Cognitive function</measure>
    <time_frame>Midline serial assessment/sample between months 2-7, in a subset</time_frame>
    <description>Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive function</measure>
    <time_frame>Endline (nine months) in a subset</time_frame>
    <description>Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">223</enrollment>
  <condition>Iron Deficiency</condition>
  <condition>Zinc Deficiency</condition>
  <arm_group>
    <arm_group_label>FeZnPM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CtrlPM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FeZnPM</intervention_name>
    <description>Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.</description>
    <arm_group_label>FeZnPM</arm_group_label>
    <other_name>biofortified pearl millet, bajra, ICTP8203-Fe</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CtrlPM</intervention_name>
    <description>Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.</description>
    <arm_group_label>CtrlPM</arm_group_label>
    <other_name>bajra, pearl millet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)&#xD;
&#xD;
          -  Hemoglobin ≥9 g/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 12 months, 0 days or older than 18 months, 30 days (at time of&#xD;
             screening/baseline visit)&#xD;
&#xD;
          -  Hemoglobin &lt; 9 g/dL and/or hemoglobinopathy&#xD;
&#xD;
          -  Presence of severe malnutrition according to Wellcome Classification (marasmus,&#xD;
             marasmic kwashiorkor, kwashiorkor, weight-for-height z-score &lt; -3)&#xD;
&#xD;
          -  Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS,&#xD;
             malaria, Dengue fever, Tuberculosis requiring &gt;1 day hospitalization&#xD;
&#xD;
          -  Children who do not have a caretaker to bring him/her to feeding center&#xD;
&#xD;
          -  Possibility of migrating out of the slum dwelling for longer than 4 weeks&#xD;
&#xD;
          -  Prior or current consumption of iron or zinc supplements in the past 1 year&#xD;
&#xD;
          -  Any known dietary allergies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saurabh Mehta, MBBS, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jere D. Haas, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julia L. Finkelstein, Sc.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard L. Canfield, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shobha Udipi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>SNDT Women's University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Padmini Ghugre</last_name>
    <role>Principal Investigator</role>
    <affiliation>SNDT Women's University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>R. Potdar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for the Study of Social Change-Mumbai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anura Kurpad</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. John's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for the Study of Social Change-Mumbai</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 051</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Research Institute</name>
      <address>
        <city>Karnataka</city>
        <zip>560 034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.N.D.T. Women's University</name>
      <address>
        <city>Mumbai</city>
        <zip>400049</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>iron</keyword>
  <keyword>zinc</keyword>
  <keyword>pearl millet</keyword>
  <keyword>India</keyword>
  <keyword>children</keyword>
  <keyword>trial</keyword>
  <keyword>randomized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 2, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02233764
org study id: IRB #: 1403004556
nct id: NCT02233764
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, iron- and zinc-biofortified pearl millet will be fed to young children in
      Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function
      in comparison to children receiving non-biofortified pearl millet.
Iron and zinc deficiency remain a major worldwide public health problem, especially in
      developing countries such as India. In this randomized study, 700 children aged 12-18 months
      from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or
      control pearl millet three times per day, six days per week, for nine months. The goal of
      this study is to examine the effects of iron and zinc biofortified millet on immune function,
      growth, and cognitive function in this age group. The key outcome measures are biomarkers of
      iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin,
      ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at
      an intermediate time point (midline; random serial sampling) and after 9 months of follow-up
      (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha
      1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To
      assess cognitive function in a subset, multiple specific aspects of memory, attention, and
      processing speed will be assessed. Higher-level, integrative cognitive abilities that require
      the coordination of multiple specific functions, such as problem-solving and exploratory
      behavior and global aspects of attention during free play with toys, will also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Iron status
time frame: Midline serial assessment/sample between months 2-7
description: Determined by serum ferritin, sTfR, and total body iron
measure: Iron status
time frame: Endline (nine months)
description: Determined by serum ferritin, sTfR, and total body iron
measure: Physical growth
time frame: Midline serial assessment/sample between months 2-7
description: As determined by length/height, weight, head circumference, and mid-upper arm circumference.
measure: Physical growth
time frame: Endline (nine months)
description: As determined by length/height, weight, head circumference, and mid-upper arm circumference.
measure: Immune function
time frame: 1 Midline serial assessment/sample between months 2-7
description: Measurement of T cell counts and vaccine response ELISA assays.
measure: Immune function
time frame: Endline (nine months)
description: Measurement of T cell counts and vaccine response ELISA assays.
measure: Cognitive function
time frame: Midline serial assessment/sample between months 2-7, in a subset
description: Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
measure: Cognitive function
time frame: Endline (nine months) in a subset
description: Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will be assessed.
arm group label: FeZnPM
arm group type: Experimental
description: The FeZnPM arm will consume iron- and zinc-biofortified pearl millet (ICTP8203-Fe).
arm group label: CtrlPM
arm group type: Active Comparator
description: The CtrlPM arm will consume conventional pearl millet three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
intervention type: Other
intervention name: FeZnPM
description: Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
arm group label: FeZnPM
other name: biofortified pearl millet, bajra, ICTP8203-Fe
intervention type: Other
intervention name: CtrlPM
description: Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
arm group label: CtrlPM
other name: bajra, pearl millet
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Months
healthy volunteers: No
last name: Saurabh Mehta, MBBS, ScD
role: Principal Investigator
affiliation: Cornell University
last name: Jere D. Haas, Ph.D.
role: Principal Investigator
affiliation: Cornell University
last name: Julia L. Finkelstein, Sc.D.
role: Principal Investigator
affiliation: Cornell University
last name: Richard L. Canfield, Ph.D.
role: Principal Investigator
affiliation: Cornell University
last name: Shobha Udipi, Ph.D.
role: Principal Investigator
affiliation: SNDT Women's University
last name: Padmini Ghugre
role: Principal Investigator
affiliation: SNDT Women's University
last name: R. Potdar
role: Principal Investigator
affiliation: Centre for the Study of Social Change-Mumbai
last name: Anura Kurpad
role: Principal Investigator
affiliation: St. John's Research Institute
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Iron Deficiencies
submitted: March 2, 2023