<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/NCT03248700</url>
  </required_header>
  <id_info>
    <org_study_id>H-2008-0020</org_study_id>
    <secondary_id>A074600</secondary_id>
    <secondary_id>AG&amp;LSC/NUTRITIONAL SCI/NUTRITI</secondary_id>
    <nct_id>NCT03248700</nct_id>
  </id_info>
  <brief_title>Vitamin A Kinetics and Mathematical Modeling in American Women</brief_title>
  <official_title>Vitamin A Kinetics and Mathematical Modeling in American Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women were given a vitamin A tracer, and blood was sampled to determine individual and group&#xD;
      vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine&#xD;
      effects of study length on model outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a longitudinal study in which American women were given an oral, stable isotope&#xD;
      tracer of vitamin A, and blood was sampled in a staggered, serial design to determine&#xD;
      individual and group vitamin A kinetics. Data were subsequently modeled using compartmental&#xD;
      analysis, and study truncation analysis was performed on data to investigate the factor of&#xD;
      study duration on resulting vitamin A kinetic models and outputs related to vitamin A&#xD;
      metabolism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2008</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total traced vitamin A mass</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Total amount of endogenous vitamin A determined by mathematical model, (µmol).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compartmental model complexity</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Required number of compartments in mathematical model needed to adequately fit data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compartmental model fractional transfer coefficients</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Model parameters adjusted to fit analytical data. Represents the fractional transfer from one compartment to another in the model, (pools/d, represented as L(i,j), the fraction of compartment J transferred to compartment I per day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum vitamin A half-life</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Half-life of vitamin A in serum, (d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin A disposal rate</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Daily loss or utilization of vitamin A, (µmol/d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin A equilibration time and partitioning</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Time taken for vitamin A to equilibrate with body stores, (d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin A tracer partitioning</measure>
    <time_frame>Baseline through 152 days</time_frame>
    <description>Body partitioning of tracer between serum and extravascular compartment(s), relative to total tracee mass. Calculated as a ratio of tracer-to-tracee ratio (TTR) in serum and extravascular stores, (TTR serum / TTR stores).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin A dietary intake</measure>
    <time_frame>Baseline</time_frame>
    <description>Vitamin A dietary intake by food frequency questionnaire, (µg retinol activity equivalents/d).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Vitamin A Kinetics</condition>
  <arm_group>
    <arm_group_label>Vitamin A tracer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A stable isotope tracer of vitamin A was given orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitamin A tracer</intervention_name>
    <description>A stable isotope tracer of vitamin A was given orally.</description>
    <arm_group_label>Vitamin A tracer</arm_group_label>
    <other_name>13C vitamin A</other_name>
    <other_name>13C retinyl acetate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI (18.5 - 24.9 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Trying to become pregnant&#xD;
&#xD;
          -  Lactating&#xD;
&#xD;
          -  Weight loss &gt; 4.5 kg during the past 3 months.&#xD;
&#xD;
          -  Actively trying to lose weight&#xD;
&#xD;
          -  Inability to refrain from drinking alcohol when requested&#xD;
&#xD;
          -  Amenorrhea&#xD;
&#xD;
          -  Acute or chronic illness including hepatitis&#xD;
&#xD;
          -  Current or previous history of anorexia or bulimia&#xD;
&#xD;
          -  Concurrent participation in other studies&#xD;
&#xD;
          -  Family member already enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry A Tanumihardjo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutritional Sciences, University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin A</mesh_term>
    <mesh_term>Retinol palmitate</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
  </intervention_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/NCT03248700
org study id: H-2008-0020
secondary id: A074600
secondary id: AG&LSC/NUTRITIONAL SCI/NUTRITI
nct id: NCT03248700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women were given a vitamin A tracer, and blood was sampled to determine individual and group
      vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine
      effects of study length on model outcomes.
This is a longitudinal study in which American women were given an oral, stable isotope
      tracer of vitamin A, and blood was sampled in a staggered, serial design to determine
      individual and group vitamin A kinetics. Data were subsequently modeled using compartmental
      analysis, and study truncation analysis was performed on data to investigate the factor of
      study duration on resulting vitamin A kinetic models and outputs related to vitamin A
      metabolism.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Total traced vitamin A mass
time frame: Baseline through 152 days
description: Total amount of endogenous vitamin A determined by mathematical model, (µmol).
measure: Compartmental model complexity
time frame: Baseline through 152 days
description: Required number of compartments in mathematical model needed to adequately fit data.
measure: Compartmental model fractional transfer coefficients
time frame: Baseline through 152 days
description: Model parameters adjusted to fit analytical data. Represents the fractional transfer from one compartment to another in the model, (pools/d, represented as L(i,j), the fraction of compartment J transferred to compartment I per day).
measure: Serum vitamin A half-life
time frame: Baseline through 152 days
description: Half-life of vitamin A in serum, (d).
measure: Vitamin A disposal rate
time frame: Baseline through 152 days
description: Daily loss or utilization of vitamin A, (µmol/d).
measure: Vitamin A equilibration time and partitioning
time frame: Baseline through 152 days
description: Time taken for vitamin A to equilibrate with body stores, (d).
measure: Vitamin A tracer partitioning
time frame: Baseline through 152 days
description: Body partitioning of tracer between serum and extravascular compartment(s), relative to total tracee mass. Calculated as a ratio of tracer-to-tracee ratio (TTR) in serum and extravascular stores, (TTR serum / TTR stores).
measure: Vitamin A dietary intake
time frame: Baseline
description: Vitamin A dietary intake by food frequency questionnaire, (µg retinol activity equivalents/d).
arm group label: Vitamin A tracer
arm group type: Experimental
description: A stable isotope tracer of vitamin A was given orally.
intervention type: Other
intervention name: Vitamin A tracer
description: A stable isotope tracer of vitamin A was given orally.
arm group label: Vitamin A tracer
other name: 13C vitamin A
other name: 13C retinyl acetate
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry A Tanumihardjo, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitamins
mesh term: Vitamin A
mesh term: Retinol palmitate
mesh term: Retinol acetate
sharing ipd: No