<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/NCT02197624</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #: 1206003117</org_study_id>
    <nct_id>NCT02197624</nct_id>
  </id_info>
  <brief_title>Genetic Variants and Iron Absorption</brief_title>
  <official_title>Metabolic Adaptation to Plant-based Diets in Asian Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron&#xD;
      status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian&#xD;
      women. The investigators hypothesize that the genetic variant could enhance iron status and&#xD;
      iron absorption in Asian women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the HFE genotype of female Asian study volunteers, we collected venous blood&#xD;
      samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT,&#xD;
      and TT and used to assess possible differences in iron status as a function of genotype. To&#xD;
      measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC&#xD;
      (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each&#xD;
      volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a&#xD;
      blood sample was collected from each woman and the amount of non-heme (57Fe) iron&#xD;
      incorporated into red blood cells was measured with magnetic sector thermal ionization mass&#xD;
      spectrometry. Possible associations between iron status and iron absorption as a function of&#xD;
      genotypes were explored. Data from this study will provide information that aims to improve&#xD;
      human health by better understanding the iron requirements of individuals with different&#xD;
      genetic background.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genotype at SNP rs9366637</measure>
    <time_frame>2 weeks after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>Up to 2 days after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Ferritin</measure>
    <time_frame>Up to 6 months after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum transferrin receptor</measure>
    <time_frame>Up to 6 months after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-heme Iron absorption in women with 2 HFE genotypes</measure>
    <time_frame>one month for screening with genotype then 2 weeks for iron absorption study</time_frame>
    <description>Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Folate</measure>
    <time_frame>Up to 6 months after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of folate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin B-12</measure>
    <time_frame>Up to 6 months after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of vitamin B-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Up to 6 months after the participant's visit to the laboratory</time_frame>
    <description>At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of C-reactive protein.</description>
  </secondary_outcome>
  <enrollment type="Actual">57</enrollment>
  <condition>Iron Absorption</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Two 10 mL blood samples and one 3 mL blood sample were collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women were eligible for the study if they met the following criteria: 1) non-pregnant and&#xD;
        between the ages of 18~35 y; 2) of East Asian descent with both maternal and paternal&#xD;
        grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand,&#xD;
        Malaysia and Singapore; 3) not taking any vitamin or mineral supplements for at least 1&#xD;
        month before the study and during the 2-week study interval; 4) no pre-existing medical&#xD;
        problems including malabsorption, blood disorders, ulcers, joint diseases or asthma that&#xD;
        might impact inflammation or Fe status; 5) not taking any prescribed medications known to&#xD;
        affect iron homeostasis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-pregnant and between the ages of 18~35 y&#xD;
&#xD;
          -  East Asian descent with both maternal and paternal grandparents from East Asia,&#xD;
             including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking or planing to take any vitamin or mineral supplements during the study period&#xD;
&#xD;
          -  pre-existing medical problems that might impact inflammation or Fe status, including&#xD;
             malabsorption, blood disorders, ulcers, joint diseases and asthma&#xD;
&#xD;
          -  taking any prescribed medications known to affect iron homeostasis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly O'Brien, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Metabolic Research Unit, Cornell University</name>
      <address>
        <city>Ithaca</city>
        <state>New York</state>
        <zip>14853</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-heme iron absorption; HFE</keyword>
  <!-- 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/NCT02197624
org study id: IRB #: 1206003117
nct id: NCT02197624
lead sponsor: 
has dmc: No
The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron
      status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian
      women. The investigators hypothesize that the genetic variant could enhance iron status and
      iron absorption in Asian women.
To determine the HFE genotype of female Asian study volunteers, we collected venous blood
      samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT,
      and TT and used to assess possible differences in iron status as a function of genotype. To
      measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC
      (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each
      volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a
      blood sample was collected from each woman and the amount of non-heme (57Fe) iron
      incorporated into red blood cells was measured with magnetic sector thermal ionization mass
      spectrometry. Possible associations between iron status and iron absorption as a function of
      genotypes were explored. Data from this study will provide information that aims to improve
      human health by better understanding the iron requirements of individuals with different
      genetic background.
observational model: Case-Only
time perspective: Prospective
measure: Genotype at SNP rs9366637
time frame: 2 weeks after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.
measure: Hemoglobin
time frame: Up to 2 days after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.
measure: Serum Ferritin
time frame: Up to 6 months after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.
measure: Serum transferrin receptor
time frame: Up to 6 months after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.
measure: Non-heme Iron absorption in women with 2 HFE genotypes
time frame: one month for screening with genotype then 2 weeks for iron absorption study
description: Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.
measure: Folate
time frame: Up to 6 months after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of folate.
measure: Vitamin B-12
time frame: Up to 6 months after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of vitamin B-12.
measure: C-reactive protein
time frame: Up to 6 months after the participant's visit to the laboratory
description: At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of C-reactive protein.
Two 10 mL blood samples and one 3 mL blood sample were collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kimberly O'Brien, PhD
role: Principal Investigator
affiliation: Cornell University
facility: 
country: United States
responsible party type: Sponsor