<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/NCT04407286</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00011960</org_study_id>
    <nct_id>NCT04407286</nct_id>
  </id_info>
  <brief_title>Vitamin D Testing and Treatment for COVID 19</brief_title>
  <official_title>Vitamin D Testing and Treatment for Adults With COVID 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southwest College of Naturopathic Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Arizona State University</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>
      This study will measure vitamin D levels in adults with COVID 19. Participants with low&#xD;
      levels of vitamin D will be entered into an open label trial of supplementation with vitamin&#xD;
      D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocol for Part 1:&#xD;
&#xD;
        -  A single blood draw at SCNM to measure levels of vitamin D and other nutrients,&#xD;
           comprehensive metabolic panel, and complete blood count with differential&#xD;
&#xD;
        -  Completing a medical history/symptom form&#xD;
&#xD;
        -  Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks&#xD;
&#xD;
        -  Authorization for release of medical records related to COVID 19 testing and/or&#xD;
           treatment.&#xD;
&#xD;
      Protocol for Part 2:&#xD;
&#xD;
        -  Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d.&#xD;
           (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)&#xD;
&#xD;
        -  After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels&#xD;
           of vitamin D, comprehensive metabolic panel, and complete blood count with differential.&#xD;
           If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If&#xD;
           vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D&#xD;
           levels are 50+ ng/ml, stop supplementation.&#xD;
&#xD;
        -  Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment&#xD;
           begins (5 minutes each time).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 19, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>This is an open label treatment study for people with COVID 19 and low levels of vitamin D</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin D levels</measure>
    <time_frame>baseline and after two weeks of vitamin D supplementation</time_frame>
    <description>change in level of Vitamin D, 25-Hydroxy between the two time points</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of COVID 19 symptoms</measure>
    <time_frame>baseline and at 2 weeks after vitamin D supplementation</time_frame>
    <description>We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Covid 19</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive vitamin D.&#xD;
The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)&#xD;
After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Oral vitamin D3 capsules</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for Part 1 (testing):&#xD;
&#xD;
          1. Adult age 18 or older&#xD;
&#xD;
          2. Previous positive test result for COVID 19&#xD;
&#xD;
          3. Able to communicate clearly in English Exclusion Criteria for Part 1 (testing): none&#xD;
&#xD;
        Inclusion Criteria for Part 2 (Vitamin D supplementation)&#xD;
&#xD;
          1. Participation in Part 1&#xD;
&#xD;
          2. Vitamin D level below 30 ng/ml&#xD;
&#xD;
          3. No abnormalities on the comprehensive metabolic panel that are clinically significant&#xD;
             to increasing the risk of an adverse reaction to vitamin D supplementation&#xD;
&#xD;
        Exclusion Criteria for Part 2 (Vitamin D supplementation):&#xD;
&#xD;
          1. Liver impairment&#xD;
&#xD;
          2. Clinical opinion of study physician that vitamin D supplementation could be harmful to&#xD;
             the participant.&#xD;
&#xD;
          3. Pregnancy&#xD;
&#xD;
          4. No symptoms for 2 weeks after positive COVID 19 test&#xD;
&#xD;
          5. Recovered from symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James B Adams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Trahan, NMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southwest College of Naturopathic Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona State University</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>December 29, 2021</last_update_submitted>
  <last_update_submitted_qc>December 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2021</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>COVID-19</mesh_term>
    <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Contact us if you wish to discuss sharing of de-identified data</ipd_description>
  </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/NCT04407286
org study id: STUDY00011960
nct id: NCT04407286
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will measure vitamin D levels in adults with COVID 19. Participants with low
      levels of vitamin D will be entered into an open label trial of supplementation with vitamin
      D.
Protocol for Part 1:

        -  A single blood draw at SCNM to measure levels of vitamin D and other nutrients,
           comprehensive metabolic panel, and complete blood count with differential

        -  Completing a medical history/symptom form

        -  Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks

        -  Authorization for release of medical records related to COVID 19 testing and/or
           treatment.

      Protocol for Part 2:

        -  Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d.
           (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)

        -  After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels
           of vitamin D, comprehensive metabolic panel, and complete blood count with differential.
           If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If
           vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D
           levels are 50+ ng/ml, stop supplementation.

        -  Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment
           begins (5 minutes each time).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is an open label treatment study for people with COVID 19 and low levels of vitamin D
primary purpose: Treatment
masking: None (Open Label)
measure: Vitamin D levels
time frame: baseline and after two weeks of vitamin D supplementation
description: change in level of Vitamin D, 25-Hydroxy between the two time points
measure: severity of COVID 19 symptoms
time frame: baseline and at 2 weeks after vitamin D supplementation
description: We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
arm group label: Treatment Group
arm group type: Experimental
description: This group will receive vitamin D.
The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: Oral vitamin D3 capsules
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James B Adams, PhD
role: Principal Investigator
affiliation: Arizona State University
last name: Sarah Trahan, NMD
role: Principal Investigator
affiliation: Southwest College of Naturopathic Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: Undecided
ipd description: Contact us if you wish to discuss sharing of de-identified data