<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/NCT03764800</url>
  </required_header>
  <id_info>
    <org_study_id>201801719A3</org_study_id>
    <nct_id>NCT03764800</nct_id>
  </id_info>
  <brief_title>The Prevalence of Micronutrient Deficiency in Early School-age Children</brief_title>
  <official_title>The Prevalence of Micronutrient Deficiency in Early School-age Children and Its Correlation With Eating Behavior, Dietary Habits, Development, Physical Activity, Nutritional Status and Health Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to assess the prevalence of deficiency in micronutrients in early school-age&#xD;
      children and its correlation with picky eating behavior, physical activity, nutritional&#xD;
      status, and health status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A structured questionnaire is used to conduct a cross-sectional descriptive study of 250&#xD;
      early school-age children aged 4-7 years (&lt;7 years old) in Taiwan. Data collection would&#xD;
      include: demographics, food preferences, eating behavior, body weight and height, body mass&#xD;
      index (BMI), physical activity, records of medical illness, peripheral cell blood count,&#xD;
      serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define&#xD;
      as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and&#xD;
      compared using standard statistical tests. The correlations among eating behavior, dietary&#xD;
      habits, development, physical activity, nutritional status, and health status, and&#xD;
      micronutrient deficiency are evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Change serum concentrations of Hb (g/dL) may be found in children's serum</measure>
    <time_frame>On the day of enrollment</time_frame>
    <description>Change serum concentrations of Hb (g/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change serum concentrations of ferritin (ng/ mL) may be found in children's serum</measure>
    <time_frame>On the day of enrollment</time_frame>
    <description>Change serum concentrations of ferritin (ng/ mL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum</measure>
    <time_frame>On the day of enrollment</time_frame>
    <description>Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.</description>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Micronutrient Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This cross-sectional descriptive study uses a structured questionnaire to elicit&#xD;
        information from parents in Taiwan who are early school-age children aged 4-7 years (&lt;7&#xD;
        years old). Participants are recruited from clinic in Chang Gung Children's medical center,&#xD;
        Chang Gung Memorial Hospital. A total of 250 participants who meet the eligibility criteria&#xD;
        are enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4-7 years old (&lt;7 years old) school-age children, legal representatives willing to&#xD;
             sign the consent form and fill in the questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At the time of the enrollment, there is an acute infection (respiratory,&#xD;
             gastrointestinal or urinary tract), and there are organic diseases (heart, lung,&#xD;
             brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsun-Chin Chao, A.P.</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Hsun-Chin Chao</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <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/NCT03764800
org study id: 201801719A3
nct id: NCT03764800
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aim to assess the prevalence of deficiency in micronutrients in early school-age
      children and its correlation with picky eating behavior, physical activity, nutritional
      status, and health status.
A structured questionnaire is used to conduct a cross-sectional descriptive study of 250
      early school-age children aged 4-7 years (<7 years old) in Taiwan. Data collection would
      include: demographics, food preferences, eating behavior, body weight and height, body mass
      index (BMI), physical activity, records of medical illness, peripheral cell blood count,
      serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define
      as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and
      compared using standard statistical tests. The correlations among eating behavior, dietary
      habits, development, physical activity, nutritional status, and health status, and
      micronutrient deficiency are evaluated.
observational model: Cohort
time perspective: Prospective
measure: Change serum concentrations of Hb (g/dL) may be found in children's serum
time frame: On the day of enrollment
description: Change serum concentrations of Hb (g/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
measure: Change serum concentrations of ferritin (ng/ mL) may be found in children's serum
time frame: On the day of enrollment
description: Change serum concentrations of ferritin (ng/ mL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
measure: Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum
time frame: On the day of enrollment
description: Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hsun-Chin Chao, A.P.
role: Study Chair
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Hsun-Chin Chao
investigator title: Attending Physician
sharing ipd: No