<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/NCT02250625</url>
  </required_header>
  <id_info>
    <org_study_id>FDI-88</org_study_id>
    <nct_id>NCT02250625</nct_id>
  </id_info>
  <brief_title>Study Vitamin D in Healthy Individuals</brief_title>
  <official_title>A Prospective Collection of Peripheral Blood Specimens to Study Vitamin D in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujirebio Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujirebio Diagnostics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To obtain sufficient specimens and correlating clinical data from a well-controlled&#xD;
      prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,&#xD;
      and to establish a collection of specimens that will support future assay discovery and&#xD;
      validation efforts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Obtain matched serum and plasma specimens collected from a minimum of 50 healthy&#xD;
           subjects in two geographic areas. Specimens will be used to determine a reference range&#xD;
           for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in&#xD;
           adults.&#xD;
&#xD;
        2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects in&#xD;
           two geographic areas. Specimens will be used to determine a reference range for a&#xD;
           vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.&#xD;
&#xD;
        3. To store any remaining specimens for use in future vitamin D assay development and to&#xD;
           evaluate as yet undetermined assays for the development of IVDs, including additional&#xD;
           vitamin D assays&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure Vitamin D in healthy individuals</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">482</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy men and women greater than or equal to 18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Males and females, age≥ 18 years Able to understand and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Males and females, age &lt;18 years Current use of dietary supplements (tablet, liquid gel or&#xD;
        liquid form only) containing high concentrations, greater than 2,000 IU per day, of vitamin&#xD;
        D.&#xD;
&#xD;
        Has a history of vitamin D deficiency Has a history or current diagnosis of any clinically&#xD;
        significant cardiac, respiratory, neurological, immunological, hematological, liver&#xD;
        disease, renal disease, gastrointestinal (GI) disorder, including any history of peptic or&#xD;
        gastric ulcers or GI bleeding, or any other condition which, in the opinion of the&#xD;
        investigator is considered chronic.&#xD;
&#xD;
        Personal history of seizures Personal history of bariatric surgery Personal history of&#xD;
        parathyroid and thyroid disease Pregnancy or lactation Is receiving systemic chemotherapy&#xD;
        or radiation treatment, has an active malignancy of any type, or has been diagnosed with&#xD;
        cancer within 5 years before screening other than basal or squamous cell skin cancers or&#xD;
        in-situ cervical cancer.&#xD;
&#xD;
        Family history of parathyroid or calcium regulatory disease Medications known to affect&#xD;
        absorption e.g. drugs that inhibit cholesterol absorption Medications known to increase&#xD;
        catabolism such as anticonvulsants, glucocorticoids, HAART (AIDS treatment) and&#xD;
        anti-rejection medications Unable to provide informed consent&#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>
  <overall_official>
    <last_name>Andreas Kogelnik, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Open Medicine Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Open Medicine Institute</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</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/NCT02250625
org study id: FDI-88
nct id: NCT02250625
lead sponsor: 
has dmc: No
To obtain sufficient specimens and correlating clinical data from a well-controlled
      prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays,
      and to establish a collection of specimens that will support future assay discovery and
      validation efforts.
1. Obtain matched serum and plasma specimens collected from a minimum of 50 healthy
           subjects in two geographic areas. Specimens will be used to determine a reference range
           for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in
           adults.

        2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects in
           two geographic areas. Specimens will be used to determine a reference range for a
           vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.

        3. To store any remaining specimens for use in future vitamin D assay development and to
           evaluate as yet undetermined assays for the development of IVDs, including additional
           vitamin D assays
observational model: Cohort
time perspective: Prospective
measure: Measure Vitamin D in healthy individuals
time frame: 1 year
Serum and plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Kogelnik, MD,PhD
role: Principal Investigator
affiliation: Open Medicine Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vitamin D Deficiency