<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/NCT03030339</url>
  </required_header>
  <id_info>
    <org_study_id>903681</org_study_id>
    <secondary_id>OPP1115464</secondary_id>
    <nct_id>NCT03030339</nct_id>
  </id_info>
  <brief_title>Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children</brief_title>
  <acronym>GloVitAS-P</acronym>
  <official_title>Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helen Keller International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Food and Nutrition Research Institute, Philippines</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Global Alliance for Improved Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Atomic Energy Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess whether children 12-18 months of age who are exposed to&#xD;
      multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above&#xD;
      the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers&#xD;
      of excessive vitamin A status, compared to children 12-18 months of age who have adequate&#xD;
      vitamin A intake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study with 3 groups, which are identified using a screening tool to&#xD;
      obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods&#xD;
      and supplements. Children and their mothers are studied over the course of one month to&#xD;
      determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution&#xD;
      method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total&#xD;
      breast milk intake (among breastfeeding children), using the dose-to-mother deuterium&#xD;
      dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers&#xD;
      of bone and liver health. Blood collection is structured in a &quot;Super-Child&quot; design, to&#xD;
      construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition&#xD;
      among children will be measured, in addition to the vitamin A intake and breast milk vitamin&#xD;
      A concentration (for breastfeeding mothers) of the mother.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total body vitamin A stores among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
    <description>Estimated using the 13C-retinol dilution method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total dietary vitamin A intake among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
    <description>Estimated using 24-hour dietary recalls, observed weighed food records, food and supplement frequency questionnaire, breast milk vitamin A concentration, and total breast milk intake (measured by the dose-to-mother deuterium dilution technique)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total breast milk intake (among breastfeeding children 12-18 mo of age)</measure>
    <time_frame>15-day study period</time_frame>
    <description>Estimating using the dose-to-mother deuterium dilution technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma or serum retinol among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma or serum retinol-binding protein among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of retinol to retinol-binding protein among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinol metabolites among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transthyretin among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone health markers among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function markers among children 12-18 mo of age</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of fortifiable foods among women</measure>
    <time_frame>28 day study period</time_frame>
    <description>Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of fortifiable foods among children</measure>
    <time_frame>28 day study period</time_frame>
    <description>Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total vitamin A intake among women</measure>
    <time_frame>28-day study period</time_frame>
    <description>Estimated using 24-hour dietary recalls and food frequency questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk vitamin A concentration among lactating women</measure>
    <time_frame>28-day study period</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Total food and nutrient intakes among women</measure>
    <time_frame>28-day study period and 30 days prior to study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Total food and nutrient intakes among children</measure>
    <time_frame>28-day study period and 30 days prior to study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant weight-for-length z score</measure>
    <time_frame>At recruitment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant length-for-age z score</measure>
    <time_frame>At recruitment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Systemic inflammation among children</measure>
    <time_frame>28-day study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Iron status among children</measure>
    <time_frame>28-day study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Zinc status among children</measure>
    <time_frame>28-day study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hepatitis infection among children</measure>
    <time_frame>28-day study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Genetic markers related to vitamin A metabolism among children</measure>
    <time_frame>28-day study period</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant hemoglobin concentration</measure>
    <time_frame>At enrollment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Infant morbidity symptoms</measure>
    <time_frame>28-day study period and previous 7 days</time_frame>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">123</enrollment>
  <condition>Vitamin A Status</condition>
  <arm_group>
    <arm_group_label>Group 1: High VA intake, recent VAS</arm_group_label>
    <description>Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: High VA intake</arm_group_label>
    <description>Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Low/adequate VA intake</arm_group_label>
    <description>Children who are not exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High VA intake, recent VAS</intervention_name>
    <description>Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.</description>
    <arm_group_label>Group 1: High VA intake, recent VAS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High VA intake</intervention_name>
    <description>Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.</description>
    <arm_group_label>Group 2: High VA intake</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low/adequate VA intake</intervention_name>
    <description>Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.</description>
    <arm_group_label>Group 3: Low/adequate VA intake</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, plasma, red and white cells, dried blood spots, breast milk&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children 12-18 months of age and their mothers in selected neighborhoods in the National&#xD;
        Capital Region of the Philippines&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 12-18 months of age, and their mothers (18-49 years of age)&#xD;
&#xD;
          -  Living in selected communities in the National Capital Region of the Philippines&#xD;
&#xD;
          -  The mother and child must plan to stay in the study area for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Child's estimated vitamin A intake and exposure to vitamin A programs must meet&#xD;
             eligibility criteria for one of three groups, based on a screening questionnaire&#xD;
             administered by an interviewer to the child's mother.&#xD;
&#xD;
        Eligibility criteria for children in Group 1: 1) consumed MNP or a multi-vitamin&#xD;
        preparation that contains vitamin A in the previous 7 days, 2) consumed at least one&#xD;
        fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk&#xD;
        or fortified milk in the past 24 hours, 4) received a high-dose VA capsule during the&#xD;
        previous month, and 5) received a screening tool 'score' suggesting VA intake above 600 µg&#xD;
        retinol/d.&#xD;
&#xD;
        Eligibility criteria for children in Group 2: will include children who: 1) consumed MNP or&#xD;
        a multi-vitamin A preparation that contains vitamin A in the previous 7 days, 2) consumed&#xD;
        at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed&#xD;
        breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule in&#xD;
        the previous 3-6 months, and 5) received a screening tool 'score' suggesting VA intake&#xD;
        above 600 µg retinol/d.&#xD;
&#xD;
        Eligibility criteria for children in Group 3: will include children who: 1) received a high&#xD;
        dose VA capsule during the previous 3-6 months, and 2) received a screening tool 'score'&#xD;
        suggesting VA intake 200-500 µg/d.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The child did not receive a high-dose VA capsule during the most recent national&#xD;
             campaign&#xD;
&#xD;
          -  The mother or child has chronic disease&#xD;
&#xD;
          -  The child has moderate or severe anemia (Hb &lt;10 g/dL)&#xD;
&#xD;
          -  The mother or child has signs or symptoms of vitamin A deficiency (Bitot's spots,&#xD;
             conjunctival xerosis, nightblindness)&#xD;
&#xD;
          -  The child has weight for length &lt; -2 z-scores of the median of the WHO growth&#xD;
             standards&#xD;
&#xD;
          -  The mother is breastfeeding more than one child&#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>Georg Lietz</last_name>
    <role>Study Director</role>
    <affiliation>Newcastle University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Block 37 Health Center</name>
      <address>
        <city>Mandaluyong</city>
        <state>National Capital Region</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin A status</keyword>
  <keyword>infant</keyword>
  <keyword>dietary assessment</keyword>
  <keyword>retinol isotope dilution</keyword>
  <keyword>breast milk intake</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>To be determined.</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/NCT03030339
org study id: 903681
secondary id: OPP1115464
nct id: NCT03030339
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The goal of this study is to assess whether children 12-18 months of age who are exposed to
      multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above
      the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers
      of excessive vitamin A status, compared to children 12-18 months of age who have adequate
      vitamin A intake.
This is an observational study with 3 groups, which are identified using a screening tool to
      obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods
      and supplements. Children and their mothers are studied over the course of one month to
      determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution
      method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total
      breast milk intake (among breastfeeding children), using the dose-to-mother deuterium
      dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers
      of bone and liver health. Blood collection is structured in a "Super-Child" design, to
      construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition
      among children will be measured, in addition to the vitamin A intake and breast milk vitamin
      A concentration (for breastfeeding mothers) of the mother.
observational model: Cohort
time perspective: Prospective
measure: Total body vitamin A stores among children 12-18 mo of age
time frame: 28-day study period
description: Estimated using the 13C-retinol dilution method
measure: Total dietary vitamin A intake among children 12-18 mo of age
time frame: 28-day study period
description: Estimated using 24-hour dietary recalls, observed weighed food records, food and supplement frequency questionnaire, breast milk vitamin A concentration, and total breast milk intake (measured by the dose-to-mother deuterium dilution technique)
measure: Total breast milk intake (among breastfeeding children 12-18 mo of age)
time frame: 15-day study period
description: Estimating using the dose-to-mother deuterium dilution technique.
measure: Plasma or serum retinol among children 12-18 mo of age
time frame: 28-day study period
measure: Plasma or serum retinol-binding protein among children 12-18 mo of age
time frame: 28-day study period
measure: Ratio of retinol to retinol-binding protein among children 12-18 mo of age
time frame: 28-day study period
measure: Retinol metabolites among children 12-18 mo of age
time frame: 28-day study period
measure: Transthyretin among children 12-18 mo of age
time frame: 28-day study period
measure: Bone health markers among children 12-18 mo of age
time frame: 28-day study period
measure: Liver function markers among children 12-18 mo of age
time frame: 28-day study period
measure: Consumption of fortifiable foods among women
time frame: 28 day study period
description: Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
measure: Consumption of fortifiable foods among children
time frame: 28 day study period
description: Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
measure: Total vitamin A intake among women
time frame: 28-day study period
description: Estimated using 24-hour dietary recalls and food frequency questionnaires
measure: Breast milk vitamin A concentration among lactating women
time frame: 28-day study period
measure: Total food and nutrient intakes among women
time frame: 28-day study period and 30 days prior to study period
measure: Total food and nutrient intakes among children
time frame: 28-day study period and 30 days prior to study period
measure: Infant weight-for-length z score
time frame: At recruitment
measure: Infant length-for-age z score
time frame: At recruitment
measure: Systemic inflammation among children
time frame: 28-day study period
measure: Iron status among children
time frame: 28-day study period
measure: Zinc status among children
time frame: 28-day study period
measure: Hepatitis infection among children
time frame: 28-day study period
measure: Genetic markers related to vitamin A metabolism among children
time frame: 28-day study period
measure: Infant hemoglobin concentration
time frame: At enrollment
measure: Infant morbidity symptoms
time frame: 28-day study period and previous 7 days
arm group label: Group 1: High VA intake, recent VAS
description: Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake
arm group label: Group 2: High VA intake
description: Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.
arm group label: Group 3: Low/adequate VA intake
description: Children who are not exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.
intervention type: Other
intervention name: High VA intake, recent VAS
description: Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.
arm group label: Group 1: High VA intake, recent VAS
intervention type: Other
intervention name: High VA intake
description: Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.
arm group label: Group 2: High VA intake
intervention type: Other
intervention name: Low/adequate VA intake
description: Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.
arm group label: Group 3: Low/adequate VA intake
Serum, plasma, red and white cells, dried blood spots, breast milk
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 18 Months
healthy volunteers: No
last name: Georg Lietz
role: Study Director
affiliation: Newcastle University
facility: 
country: Philippines
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: To be determined.