<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/NCT03228173</url>
  </required_header>
  <id_info>
    <org_study_id>State Fair</org_study_id>
    <nct_id>NCT03228173</nct_id>
  </id_info>
  <brief_title>Iron Deficiency in Female State Fair Attendees</brief_title>
  <official_title>Iron Deficiency, Depression, and Other Affective Disorders in Female State Fair Attendees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine iron deficiency symptoms and biochemical iron status based on&#xD;
      hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron deficiency affects nearly 2 billion people globally, and it is among the most common&#xD;
      risk factors for disability and death. In its most extreme presentation, it results in&#xD;
      anemia, where the RBC count of the individual is markedly low, hindering oxygen transport.&#xD;
      Anemia has a remarkable global presence, affecting approximately one third of the world's&#xD;
      population. Though there are multiple causes for anemia, the World Health Organization (WHO)&#xD;
      estimates that the most common cause for anemia on the planet is iron deficiency. Although&#xD;
      findings from the US indicate that iron deficiency is less prevalent than in many other&#xD;
      nations, iron deficiency is still a pervasive national public health concern. A study that&#xD;
      analyzed the National Health and Nutrition Examination Survey (NHANES) data from 2007-2010&#xD;
      indicated that US children 5 years of age and younger have an anemia incidence of 3.2&#xD;
      percent.&#xD;
&#xD;
      Incidence of depression varies based on diagnostic tools used and categories included, as&#xD;
      well as the country, gender, age, and socioeconomic status of individuals. Globally, it is&#xD;
      estimated that between 4 and 10 percent of people experience major depressive disorder (MDD)&#xD;
      while between 2.5 and 5 percent experience dysthymia, a depression that involves less severe&#xD;
      symptoms but has a chronic manifestation. On average, the first onset of depression is 20&#xD;
      years old, though this figure is highly variable. It has consistently been demonstrated that&#xD;
      females experience a much higher incidence of depression than males. MDD has repeatedly been&#xD;
      reported in females at rates 1.5 to 3 times that of males, and female dysthymia has been&#xD;
      reported at 2 times that of males.&#xD;
&#xD;
      The current state of the literature on the connection between mental health and iron status&#xD;
      is further muddled by subjective, self-reported assessments and a lack of randomized&#xD;
      controlled trials, but the evidence certainly suggests an association. Affective&#xD;
      characteristics studied in relation to iron deficiency include irritability, anger, or mood;&#xD;
      depression, both as postpartum depression (PPD) or depression independently; and perceived&#xD;
      QOL. Differences in assessment tools as well as length and dosage of iron treatment likely&#xD;
      play a pivotal role in discordant results. Most studies also include fatigue as a primary&#xD;
      outcome as it is closely tied to these affective characteristics.&#xD;
&#xD;
      The aim of this study is to further investigate iron status and iron deficiency symptoms in&#xD;
      menstruating females. It builds on the existing research for use of cutoff values for various&#xD;
      biochemical assessments of iron as well as for stages of deficiency in which symptoms are&#xD;
      experienced. In addition, the association between iron status, measured either biochemically&#xD;
      or by self-reported iron deficiency symptoms, and depression was examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>iron deficiency symptoms</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <enrollment type="Actual">190</enrollment>
  <condition>Iron-deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <condition>Iron Deficiency (Without Anemia)</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum from each subject was coded and frozen in a -80 degrees C in a lab at the University of&#xD;
      Minnesota&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Because menstruation causes much lower iron stores in adult females, this study targeted&#xD;
        adult, menstruating, non-pregnant females. Additionally, inflammation and iron metabolism&#xD;
        disorders can result in biochemical iron values that are difficult to interpret, so these&#xD;
        conditions were excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-pregnant&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  18-45 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  outside age range&#xD;
&#xD;
          -  post-menopausal&#xD;
&#xD;
          -  experiencing one of the following inflammatory or iron metabolism disorders: active&#xD;
             treatment for cancer, irritable bowel syndrome, colitis, Chron's disease, chronic&#xD;
             heart failure, chronic kidney disease, chronic parasitic infection, hemochromatosis,&#xD;
             human immunodeficiency virus, polycystic ovarian syndrome, respiratory illness, sickle&#xD;
             cell anemia, and thalassemia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pre-menopausal females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Gallaher, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota - Department of Food Science and Nutrition</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognition</keyword>
  <keyword>Executive functioning</keyword>
  <keyword>Depression</keyword>
  <keyword>Affect</keyword>
  <keyword>adult females</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 31, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03228173/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 29, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03228173/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03228173/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03228173
org study id: State Fair
nct id: NCT03228173
lead sponsor: 
collaborator: 
has dmc: Yes
This study aims to examine iron deficiency symptoms and biochemical iron status based on
      hemoglobin, hematocrit, ferritin, and total iron binding capacity in menstruating females.
Iron deficiency affects nearly 2 billion people globally, and it is among the most common
      risk factors for disability and death. In its most extreme presentation, it results in
      anemia, where the RBC count of the individual is markedly low, hindering oxygen transport.
      Anemia has a remarkable global presence, affecting approximately one third of the world's
      population. Though there are multiple causes for anemia, the World Health Organization (WHO)
      estimates that the most common cause for anemia on the planet is iron deficiency. Although
      findings from the US indicate that iron deficiency is less prevalent than in many other
      nations, iron deficiency is still a pervasive national public health concern. A study that
      analyzed the National Health and Nutrition Examination Survey (NHANES) data from 2007-2010
      indicated that US children 5 years of age and younger have an anemia incidence of 3.2
      percent.

      Incidence of depression varies based on diagnostic tools used and categories included, as
      well as the country, gender, age, and socioeconomic status of individuals. Globally, it is
      estimated that between 4 and 10 percent of people experience major depressive disorder (MDD)
      while between 2.5 and 5 percent experience dysthymia, a depression that involves less severe
      symptoms but has a chronic manifestation. On average, the first onset of depression is 20
      years old, though this figure is highly variable. It has consistently been demonstrated that
      females experience a much higher incidence of depression than males. MDD has repeatedly been
      reported in females at rates 1.5 to 3 times that of males, and female dysthymia has been
      reported at 2 times that of males.

      The current state of the literature on the connection between mental health and iron status
      is further muddled by subjective, self-reported assessments and a lack of randomized
      controlled trials, but the evidence certainly suggests an association. Affective
      characteristics studied in relation to iron deficiency include irritability, anger, or mood;
      depression, both as postpartum depression (PPD) or depression independently; and perceived
      QOL. Differences in assessment tools as well as length and dosage of iron treatment likely
      play a pivotal role in discordant results. Most studies also include fatigue as a primary
      outcome as it is closely tied to these affective characteristics.

      The aim of this study is to further investigate iron status and iron deficiency symptoms in
      menstruating females. It builds on the existing research for use of cutoff values for various
      biochemical assessments of iron as well as for stages of deficiency in which symptoms are
      experienced. In addition, the association between iron status, measured either biochemically
      or by self-reported iron deficiency symptoms, and depression was examined.
observational model: Cohort
time perspective: Cross-Sectional
measure: iron deficiency symptoms
time frame: Baseline
serum from each subject was coded and frozen in a -80 degrees C in a lab at the University of
      Minnesota
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pre-menopausal females
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Gallaher, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
provided document: 
provided document: 
provided document: 