<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/NCT01696409</url>
  </required_header>
  <id_info>
    <org_study_id>Vitamin D and Gene Expression</org_study_id>
    <nct_id>NCT01696409</nct_id>
  </id_info>
  <brief_title>The Effect Of Vitamin D On Measures Of Bone Health And Gene Expression</brief_title>
  <official_title>The Effect of Vitamin D on Measures of Bone Health and Gene Expression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in&#xD;
      adults in the United States. Vitamin D deficiency has been connected to many chronic health&#xD;
      diseases. The goal of this innovative research is to identify how vitamin D is able to have&#xD;
      such wide ranging health benefits. This study will determine which genes are turned on and&#xD;
      turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per&#xD;
      day. Results should provide important new insights about the health benefits of vitamin D for&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D, commonly known as the sunshine vitamin, is produced in the skin from sun exposure&#xD;
      as well as from dietary sources. However, very few foods naturally contain vitamin D and the&#xD;
      amount of vitamin D in fortified foods typically, 100 IU per serving, has been totally&#xD;
      inadequate in satisfying adults vitamin D requirement, which is now been estimated to be at&#xD;
      least 2,000 IU of vitamin D a day. As a result, vitamin D deficiency is rapidly being&#xD;
      recognized world-wide as the most common vitamin deficiency. Upwards of 50-100% of children&#xD;
      and adults have been reported as being vitamin D deficient depending on ethnicity, latitude&#xD;
      and skin pigmentation. The investigators reported in women at the time of delivery that 76%&#xD;
      of mothers and 81% of newborns were vitamin D deficient despite the fact that the mother was&#xD;
      taking a prenatal vitamin containing 400 IU vitamin D and drinking two glasses of milk a day.&#xD;
      The investigators also reported 30-80% vitamin D deficiency rates in white and black&#xD;
      children, healthy young, middle aged and older adults. There have been numerous epidemiologic&#xD;
      and clinical observations relating vitamin D deficiency to many chronic diseases and there&#xD;
      are many isolated but no comprehensive studies evaluating various genes that are either&#xD;
      suppressed or enhanced by 1,25-dihydroxyvitamin D [1,25(OH)2D]. It has been estimated that&#xD;
      upwards of 2000 genes are directly or indirectly influence by 1,25(OH)2 D. To date, however,&#xD;
      there have not been any genomic signatures identified in humans in response to correction of&#xD;
      vitamin D deficiency. The goal of this pilot study is to determine whether or not vitamin D3&#xD;
      supplementation will affect biomarkers for calcium and bone metabolism, and how they alter&#xD;
      gene expression biomarkers, especially genes related to the non-skeletal actions of vitamin&#xD;
      D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Gene Expression</measure>
    <time_frame>Baseline and Final Visits</time_frame>
    <description>Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <description>400 IU vitamin D3 once a day for 2 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <description>2000 IU Vitamin D3 once/day for 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>400 IU vitamin D3</intervention_name>
    <description>Take 400 IU once/day for 2 months</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>2000 IU vitamin D3</intervention_name>
    <description>2000 IU vitamin D3 once/day for 2 months</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Buffy coat has been retained from whole blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy Students from Boston University Medical School&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female adults of all races ages 18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Pregnant and lactating women.&#xD;
&#xD;
             2. Current or recent history of hepatic or renal disease&#xD;
&#xD;
             3. History of taking a daily supplement that contains more than 400 IU vitamin D2 or&#xD;
             vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one&#xD;
             of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex&#xD;
             (calcipotriol), Hectorol (vitamin D pro hormone)&#xD;
&#xD;
             4. Subjects who are taking antiseizure medications or glucocorticoids.&#xD;
&#xD;
             5. Exposure to a tanning bed or tanning on a beach for more than eight hours within&#xD;
             the past month.&#xD;
&#xD;
             6. Known history of elevated calcium. (&gt; 10.5 mg% (mg/dl))&#xD;
&#xD;
             7. History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat Malabsorption&#xD;
             Syndrome, Crohn's Disease)&#xD;
&#xD;
             8. Unwilling to consent to this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael F Holick, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Michael F. Holick</investigator_full_name>
    <investigator_title>Dr. Michael Holick</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</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/NCT01696409
org study id: Vitamin D and Gene Expression
nct id: NCT01696409
lead sponsor: 
has dmc: No
Vitamin D deficiency is now recognized as one of the most common vitamin deficiencies in
      adults in the United States. Vitamin D deficiency has been connected to many chronic health
      diseases. The goal of this innovative research is to identify how vitamin D is able to have
      such wide ranging health benefits. This study will determine which genes are turned on and
      turned off in adults who receive 2000 IU vitamin D3 per day compared to 400 IU vitamin D3 per
      day. Results should provide important new insights about the health benefits of vitamin D for
      adults.
Vitamin D, commonly known as the sunshine vitamin, is produced in the skin from sun exposure
      as well as from dietary sources. However, very few foods naturally contain vitamin D and the
      amount of vitamin D in fortified foods typically, 100 IU per serving, has been totally
      inadequate in satisfying adults vitamin D requirement, which is now been estimated to be at
      least 2,000 IU of vitamin D a day. As a result, vitamin D deficiency is rapidly being
      recognized world-wide as the most common vitamin deficiency. Upwards of 50-100% of children
      and adults have been reported as being vitamin D deficient depending on ethnicity, latitude
      and skin pigmentation. The investigators reported in women at the time of delivery that 76%
      of mothers and 81% of newborns were vitamin D deficient despite the fact that the mother was
      taking a prenatal vitamin containing 400 IU vitamin D and drinking two glasses of milk a day.
      The investigators also reported 30-80% vitamin D deficiency rates in white and black
      children, healthy young, middle aged and older adults. There have been numerous epidemiologic
      and clinical observations relating vitamin D deficiency to many chronic diseases and there
      are many isolated but no comprehensive studies evaluating various genes that are either
      suppressed or enhanced by 1,25-dihydroxyvitamin D [1,25(OH)2D]. It has been estimated that
      upwards of 2000 genes are directly or indirectly influence by 1,25(OH)2 D. To date, however,
      there have not been any genomic signatures identified in humans in response to correction of
      vitamin D deficiency. The goal of this pilot study is to determine whether or not vitamin D3
      supplementation will affect biomarkers for calcium and bone metabolism, and how they alter
      gene expression biomarkers, especially genes related to the non-skeletal actions of vitamin
      D.
observational model: Cohort
time perspective: Prospective
measure: Gene Expression
time frame: Baseline and Final Visits
description: Measurement of mRNA levels from genes specific to bone, calcium, and non-skeletal functions.
arm group label: Arm A
description: 400 IU vitamin D3 once a day for 2 months
arm group label: Arm B
description: 2000 IU Vitamin D3 once/day for 2 months
intervention type: Dietary Supplement
intervention name: 400 IU vitamin D3
description: Take 400 IU once/day for 2 months
arm group label: Arm A
intervention type: Dietary Supplement
intervention name: 2000 IU vitamin D3
description: 2000 IU vitamin D3 once/day for 2 months
arm group label: Arm B
Buffy coat has been retained from whole blood.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael F Holick, PhD, MD
role: Principal Investigator
affiliation: BUMC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Michael F. Holick
investigator title: Dr. Michael Holick
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No