<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/NCT03274726</url>
  </required_header>
  <id_info>
    <org_study_id>CDC-NCCDPHP-2011-17</org_study_id>
    <nct_id>NCT03274726</nct_id>
  </id_info>
  <brief_title>Iron Status of Women and Young Children in the United States</brief_title>
  <acronym>NHANES</acronym>
  <official_title>Iron Status of Toddlers, Non-pregnant, and Pregnant Women in the United States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centers for Disease Control and Prevention</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 analysis describes the distribution of TBI and the prevalence of iron deficiency (ID)&#xD;
      and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and&#xD;
      soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of&#xD;
      populations in the United States.&#xD;
&#xD;
      Objective: This analysis describes the distribution of TBI and the prevalence of iron&#xD;
      deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and&#xD;
      pregnant women.&#xD;
&#xD;
      Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010),&#xD;
      non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES&#xD;
      1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce&#xD;
      prevalence estimates of ID and IDA for each target population. All analyses were weighted to&#xD;
      account for the complex survey design&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1999</start_date>
  <completion_date type="Actual">December 1, 2010</completion_date>
  <primary_completion_date type="Actual">December 1, 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Iron Deficiency</measure>
    <time_frame>1999-2010</time_frame>
    <description>Total Body Iron &lt;0 mg/kg</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Nutritional Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        NHANES is a nationally-representative, cross-sectional study of nutrition and health for&#xD;
        individuals residing in the U.S.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Included:&#xD;
&#xD;
          -  Children ages 12-23 months and Women ages 12-49 years&#xD;
&#xD;
          -  Those who completed the MEC&#xD;
&#xD;
        Excluded:&#xD;
&#xD;
        - Those missing data on iron biomarkers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centers for Disease Control and Prevention</investigator_affiliation>
    <investigator_full_name>Priya Gupta</investigator_full_name>
    <investigator_title>ORISE Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT03274726
org study id: CDC-NCCDPHP-2011-17
nct id: NCT03274726
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID)
      and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.
Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and
      soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of
      populations in the United States.

      Objective: This analysis describes the distribution of TBI and the prevalence of iron
      deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and
      pregnant women.

      Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010),
      non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES
      1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce
      prevalence estimates of ID and IDA for each target population. All analyses were weighted to
      account for the complex survey design
observational model: Other
time perspective: Cross-Sectional
measure: Iron Deficiency
time frame: 1999-2010
description: Total Body Iron <0 mg/kg
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Centers for Disease Control and Prevention
investigator full name: Priya Gupta
investigator title: ORISE Fellow
mesh term: Iron Deficiencies
mesh term: Malnutrition