<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/NCT01688102</url>
  </required_header>
  <id_info>
    <org_study_id>MPO-0787</org_study_id>
    <nct_id>NCT01688102</nct_id>
  </id_info>
  <brief_title>The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile</brief_title>
  <official_title>The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rockefeller University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rockefeller University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants in this study will be randomized to receive either oral vitamin D pills OR&#xD;
      ultraviolet light treatment. The investigators will compare how these two methods of raising&#xD;
      vitamin D levels will affect cholesterol levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Potential subjects will be screened for eligibility, including serum 25(OH)D levels &lt;20ng/ml.&#xD;
      Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000&#xD;
      units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks.&#xD;
      Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be&#xD;
      measured monthly. For participants with levels &lt;35 ng/ml, additional doses of oral vitamin D3&#xD;
      or UV radiation will be administered.&#xD;
&#xD;
      A subset of participants from both groups will participate in a skin biopsy cohort, where&#xD;
      skin biopsies are obtained before and after 8 weeks of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LDL Cholesterol Level</measure>
    <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Total Cholesterol</measure>
    <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
    <description>Change in Total Cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL Cholesterol</measure>
    <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Triglycerides</measure>
    <time_frame>baseline 6 months or last observation carried forward (minimum 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in C Reactive Protein</measure>
    <time_frame>baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 25(OH)D</measure>
    <time_frame>baseline vs. 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Calcium</measure>
    <time_frame>baseline vs. 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parathyroid Hormone (PTH)</measure>
    <time_frame>baseline vs.6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation Between Change in LDL Cholesterol and Change in Calcium</measure>
    <time_frame>2 months</time_frame>
    <description>The Correlation between change in LDL cholesterol and change in serum calcium</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation Between Change in LDL Cholesterol and Change in PTH</measure>
    <time_frame>2 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gene Expression Changes in Peripheral Blood</measure>
    <time_frame>baseline vs. 2 months</time_frame>
    <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gene Expression Changes in Skin</measure>
    <time_frame>baseline vs. 2 months</time_frame>
    <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Oral Vitamin D3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultraviolet Light</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral Vitamin D3</intervention_name>
    <description>50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
    <arm_group_label>Oral Vitamin D3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Ultraviolet Light</intervention_name>
    <description>16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
    <arm_group_label>Ultraviolet Light</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Vitamin D 25-OH level &lt; 20 ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serum calcium &gt; 10.5 mg/dl&#xD;
&#xD;
          2. Serum phosphorus &gt; 5.5 mg/dl&#xD;
&#xD;
          3. Serum parathyroid hormone (PTH) level &lt; 12 pg/ml&#xD;
&#xD;
          4. LDL cholesterol &gt; 190 mg/dl&#xD;
&#xD;
          5. History of recent acute infection (within 1 month)&#xD;
&#xD;
          6. Glomerular filtration rate(GFR) &lt; 60 mL/min&#xD;
&#xD;
          7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or&#xD;
             alanine transferase (ALT) &gt; 3x ULN)&#xD;
&#xD;
          8. Current use of Vitamin D &gt; 400 IU/day&#xD;
&#xD;
          9. Current use of any statins, fibrates, niacin, or ezetimibe&#xD;
&#xD;
         10. Current use of any medications affecting sensitivity to UV light&#xD;
&#xD;
         11. Pregnancy (self-reported)&#xD;
&#xD;
         12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use&#xD;
             while participating in the study&#xD;
&#xD;
         13. history of malignancy not in remission (&gt; 6 months)&#xD;
&#xD;
         14. History of malignant melanoma&#xD;
&#xD;
         15. Participation in an investigational drug study within 30 days of the screening visit&#xD;
&#xD;
         16. Any medical, psychological or social condition that, in the opinion of the&#xD;
             Investigator, would jeopardize the health or well-being of the participant during any&#xD;
             study procedures or the integrity of the data.&#xD;
&#xD;
         17. History of any non-melanoma skin cancer&#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>Manish Ponda, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Rockefeller University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Rockefeller University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>August 2, 2016</results_first_submitted>
  <results_first_submitted_qc>August 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 23, 2016</results_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rockefeller University</investigator_affiliation>
    <investigator_full_name>Manish Ponda</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Investigation</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>Cholecalciferol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Vitamin D3</title>
          <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
        </group>
        <group group_id="P2">
          <title>Ultraviolet Light</title>
          <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Vitamin D3</title>
          <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
        </group>
        <group group_id="B2">
          <title>Ultraviolet Light</title>
          <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" spread="12"/>
                    <measurement group_id="B2" value="39" spread="12"/>
                    <measurement group_id="B3" value="42" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in LDL Cholesterol Level</title>
        <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in LDL Cholesterol Level</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="18.4"/>
                    <measurement group_id="O2" value="1.4" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Cholesterol</title>
        <description>Change in Total Cholesterol</description>
        <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Cholesterol</title>
          <description>Change in Total Cholesterol</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="22"/>
                    <measurement group_id="O2" value="2.0" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HDL Cholesterol</title>
        <time_frame>baseline and 6 months or last observation carried forward (minimum 2 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HDL Cholesterol</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="8.1"/>
                    <measurement group_id="O2" value="0.3" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Triglycerides</title>
        <time_frame>baseline 6 months or last observation carried forward (minimum 2 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Triglycerides</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="35.4"/>
                    <measurement group_id="O2" value="1.7" spread="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in C Reactive Protein</title>
        <time_frame>baseline and 6 months</time_frame>
        <population>Data analyzed are only for those who completed 6 months of therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in C Reactive Protein</title>
          <population>Data analyzed are only for those who completed 6 months of therapy</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="6.87"/>
                    <measurement group_id="O2" value="-.11" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 25(OH)D</title>
        <time_frame>baseline vs. 6 months</time_frame>
        <population>Data only for those who completed 6 months of therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 25(OH)D</title>
          <population>Data only for those who completed 6 months of therapy</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.7" spread="8.0"/>
                    <measurement group_id="O2" value="15.6" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Serum Calcium</title>
        <time_frame>baseline vs. 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Calcium</title>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".09" spread=".35"/>
                    <measurement group_id="O2" value=".07" spread=".29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Parathyroid Hormone (PTH)</title>
        <time_frame>baseline vs.6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Parathyroid Hormone (PTH)</title>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="19"/>
                    <measurement group_id="O2" value="-9" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Correlation Between Change in LDL Cholesterol and Change in Calcium</title>
        <description>The Correlation between change in LDL cholesterol and change in serum calcium</description>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Change in LDL Cholesterol and Change in Calcium</title>
          <description>The Correlation between change in LDL cholesterol and change in serum calcium</description>
          <units>Pearson correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24"/>
                    <measurement group_id="O2" value=".16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Correlation Between Change in LDL Cholesterol and Change in PTH</title>
        <time_frame>2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Change in LDL Cholesterol and Change in PTH</title>
          <units>Pearson correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.01"/>
                    <measurement group_id="O2" value=".18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Gene Expression Changes in Peripheral Blood</title>
        <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
        <time_frame>baseline vs. 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Gene Expression Changes in Peripheral Blood</title>
          <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
          <units>GSEA Normalized Enrichment Score</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Interferon-alpha response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14"/>
                    <measurement group_id="O2" value="-4.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interferon-gamma response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.41"/>
                    <measurement group_id="O2" value="-4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Gene Expression Changes in Skin</title>
        <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
        <time_frame>baseline vs. 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Vitamin D3</title>
            <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
          </group>
          <group group_id="O2">
            <title>Ultraviolet Light</title>
            <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
          </group>
        </group_list>
        <measure>
          <title>Gene Expression Changes in Skin</title>
          <description>Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.</description>
          <units>GSEA Normalized Enrichment Score</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Interferon-alpha response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08"/>
                    <measurement group_id="O2" value="-2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interferon-gamma response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12"/>
                    <measurement group_id="O2" value="-2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Oral Vitamin D3</title>
          <description>Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of oral vitamin D.&#xD;
Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed</description>
        </group>
        <group group_id="E2">
          <title>Ultraviolet Light</title>
          <description>Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain &lt;35 ng/ml, subjects will receive additional doses of narrow band UVB.&#xD;
Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hip Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI Distress</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Constipation/Hemmorhoids</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin erythema/burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Skin dryness/irritation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Manish Ponda</name_or_title>
      <organization>The Rockefeller University</organization>
      <phone>212-327-7631</phone>
      <email>mponda@rockefeller.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01688102
org study id: MPO-0787
nct id: NCT01688102
lead sponsor: 
has dmc: No
Participants in this study will be randomized to receive either oral vitamin D pills OR
      ultraviolet light treatment. The investigators will compare how these two methods of raising
      vitamin D levels will affect cholesterol levels.
Potential subjects will be screened for eligibility, including serum 25(OH)D levels <20ng/ml.
      Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000
      units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks.
      Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be
      measured monthly. For participants with levels <35 ng/ml, additional doses of oral vitamin D3
      or UV radiation will be administered.

      A subset of participants from both groups will participate in a skin biopsy cohort, where
      skin biopsies are obtained before and after 8 weeks of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in LDL Cholesterol Level
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
measure: Change in Total Cholesterol
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
description: Change in Total Cholesterol
measure: Change in HDL Cholesterol
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
measure: Change in Triglycerides
time frame: baseline 6 months or last observation carried forward (minimum 2 months)
measure: Change in C Reactive Protein
time frame: baseline and 6 months
measure: Change in 25(OH)D
time frame: baseline vs. 6 months
measure: Change in Serum Calcium
time frame: baseline vs. 6 months
measure: Change in Parathyroid Hormone (PTH)
time frame: baseline vs.6 months
measure: Correlation Between Change in LDL Cholesterol and Change in Calcium
time frame: 2 months
description: The Correlation between change in LDL cholesterol and change in serum calcium
measure: Correlation Between Change in LDL Cholesterol and Change in PTH
time frame: 2 months
measure: Gene Expression Changes in Peripheral Blood
time frame: baseline vs. 2 months
description: Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.
measure: Gene Expression Changes in Skin
time frame: baseline vs. 2 months
description: Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.
arm group label: Oral Vitamin D3
arm group type: Active Comparator
description: Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.
arm group label: Ultraviolet Light
arm group type: Active Comparator
description: Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.
intervention type: Dietary Supplement
intervention name: Oral Vitamin D3
description: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed
arm group label: Oral Vitamin D3
intervention type: Radiation
intervention name: Ultraviolet Light
description: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes
arm group label: Ultraviolet Light
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manish Ponda, MD MS
role: Principal Investigator
affiliation: The Rockefeller University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rockefeller University
investigator full name: Manish Ponda
investigator title: Assistant Professor of Clinical Investigation
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol
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point of contact: 