<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/NCT03276247</url>
  </required_header>
  <id_info>
    <org_study_id>HEIRS-womenrepage</org_study_id>
    <nct_id>NCT03276247</nct_id>
  </id_info>
  <brief_title>Iron Status in Women of Reproductive Age Reproductive Age</brief_title>
  <official_title>Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Victor Gordeuk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in&#xD;
      the United States and Canada using de-identified data from the HEIRS study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or&#xD;
      older, in the primary care setting. Participants were recruited from four centers in the U.S&#xD;
      .and one in Canada from February 2001 to February 2003. We will evaluate results for women&#xD;
      aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower&#xD;
      detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and&#xD;
      therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF&#xD;
      concentrations, possibly indicative of elevated iron stores, will be classified by two&#xD;
      definitions: 1) SF concentration &gt; 300 μg/L and 2) SF &gt;200 μg/L in combination with TSAT&#xD;
      &gt;45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will&#xD;
      be used to identify independent associations with measures of iron deficiency and elevated&#xD;
      iron stores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Elevated serum ferritin</measure>
    <time_frame>One measurement was made at the time of recruitment and this is the measurement that will be analyzed.</time_frame>
    <description>Serum ferritin &gt;300 ug/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elevated serum ferritin and transferrin saturation</measure>
    <time_frame>One measurement was made at the time of recruitment and this is the measurement that will be analyzed.</time_frame>
    <description>Serum ferritin &gt;200 ug/L and transferrin saturation &gt;45%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron deficiency</measure>
    <time_frame>One measurement was made at the time of recruitment and this is the measurement that will be analyzed.</time_frame>
    <description>Serum ferritin &lt;15ug/L</description>
  </primary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">22042</enrollment>
  <condition>Iron Metabolism Disorders</condition>
  <arm_group>
    <arm_group_label>Asian American non-pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African American non-pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hispanic American non-pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White non-pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asian American pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>African American pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hispanic American pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White pregnant</arm_group_label>
    <description>Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation</intervention_name>
    <description>observation</description>
    <arm_group_label>African American non-pregnant</arm_group_label>
    <arm_group_label>African American pregnant</arm_group_label>
    <arm_group_label>Asian American non-pregnant</arm_group_label>
    <arm_group_label>Asian American pregnant</arm_group_label>
    <arm_group_label>Hispanic American non-pregnant</arm_group_label>
    <arm_group_label>Hispanic American pregnant</arm_group_label>
    <arm_group_label>White non-pregnant</arm_group_label>
    <arm_group_label>White pregnant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care women included in the HEIRS study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. primary care women included in the HEIRS study with in the age range of this study&#xD;
&#xD;
          2. Self designation as Asian American, African American, Hispanic American or White.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &gt;44 years&#xD;
&#xD;
          2. Self-described ethnicity other in than inclusion criterion 2.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Victor R Gordeuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Victor Gordeuk</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Iron Metabolism Disorders</mesh_term>
  </condition_browse>
  <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/NCT03276247
org study id: HEIRS-womenrepage
nct id: NCT03276247
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in
      the United States and Canada using de-identified data from the HEIRS study.
HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or
      older, in the primary care setting. Participants were recruited from four centers in the U.S
      .and one in Canada from February 2001 to February 2003. We will evaluate results for women
      aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower
      detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and
      therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF
      concentrations, possibly indicative of elevated iron stores, will be classified by two
      definitions: 1) SF concentration > 300 μg/L and 2) SF >200 μg/L in combination with TSAT
      >45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will
      be used to identify independent associations with measures of iron deficiency and elevated
      iron stores.
observational model: Cohort
time perspective: Cross-Sectional
measure: Elevated serum ferritin
time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
description: Serum ferritin >300 ug/L
measure: Elevated serum ferritin and transferrin saturation
time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
description: Serum ferritin >200 ug/L and transferrin saturation >45%
measure: Iron deficiency
time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
description: Serum ferritin <15ug/L
arm group label: Asian American non-pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.
arm group label: African American non-pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.
arm group label: Hispanic American non-pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.
arm group label: White non-pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.
arm group label: Asian American pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.
arm group label: African American pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.
arm group label: Hispanic American pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.
arm group label: White pregnant
description: Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.
intervention type: Other
intervention name: observation
description: observation
arm group label: African American non-pregnant
arm group label: African American pregnant
arm group label: Asian American non-pregnant
arm group label: Asian American pregnant
arm group label: Hispanic American non-pregnant
arm group label: Hispanic American pregnant
arm group label: White non-pregnant
arm group label: White pregnant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 44 Years
last name: Victor R Gordeuk, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Victor Gordeuk
investigator title: Professor of Medicine
mesh term: Metabolic Diseases
mesh term: Iron Metabolism Disorders
sharing ipd: No