<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/NCT04476745</url>
  </required_header>
  <id_info>
    <org_study_id>2020-PHA-16</org_study_id>
    <nct_id>NCT04476745</nct_id>
  </id_info>
  <brief_title>The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People</brief_title>
  <official_title>The Effect of Weekly 50,000 IU Vitamin D3 Supplements on the Serum Levels of Selected Cytokines Involved in Cytokine Storm of Covid-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People With Vitamin D Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Applied Science Private University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Applied Science Private University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected&#xD;
      cytokines involved in cytokine storm of Covid-19; A randomized clinical trial in the Covid-19&#xD;
      uninfected people with vitamin D deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No data are available on the effect of Weekly 50,000 IU vitamin D3 supplements on the serum&#xD;
      levels of selected cytokines involved in cytokine storm of Covid-19 in the Covid-19&#xD;
      uninfected Jordanian people with vitamin D deficiency. This study was designed to investigate&#xD;
      whether a high dose of vitamin D3 (50,000 IU) / week for 8 weeks supplementation has a&#xD;
      potential effect on cytokine storm of Covid-19; such as IL-1 beta, IL-6, and TNF in the&#xD;
      Covid-19 uninfected Jordanian people with vitamin D deficiency.&#xD;
&#xD;
      This study aims to assess whether high doses of vitamin D3 may improve immune responses&#xD;
      against COVID-19 infection in uninfected Jordanian peoples. We hypothesize that Weekly 50,000&#xD;
      IU vitamin D3 supplements will significantly change immune responses compared with the&#xD;
      control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-1 beta</measure>
    <time_frame>8 weeks</time_frame>
    <description>seum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6</measure>
    <time_frame>8 weeks</time_frame>
    <description>serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TNF</measure>
    <time_frame>8 weeks</time_frame>
    <description>serum levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum concentrations of 25-hydroxyvitamin D</measure>
    <time_frame>8 weeks</time_frame>
    <description>ng/ml</description>
  </secondary_outcome>
  <other_outcome>
    <measure>lipid profile parameters</measure>
    <time_frame>8 weeks</time_frame>
    <description>seum levels</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cytokine Storm</condition>
  <arm_group>
    <arm_group_label>Experimental: VD3 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group No intervention was given</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Vitamin D3</intervention_name>
    <description>Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks</description>
    <arm_group_label>Experimental: VD3 group</arm_group_label>
    <other_name>cholecalciferol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age ≥30 years old Male and female Jordanian ASU students and employees who live in Amman.&#xD;
        Informed written consent from the participant prior to the start of the study. a serum&#xD;
        25(OH)D concentration less than 30 ng/mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any eligible subject refuses to apply with informed written consent before the start of the&#xD;
        study. Men or women previously diagnosed with chronic diseases, including kidney disease or&#xD;
        GIT problems. Who are receiving vitamin D3 supplements (3 months before the start of the&#xD;
        study). Pregnant, Breastfeeding females, Females using hormonal contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud S Abu-Samak, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dana A Bader, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mahmoud S Abu-Samak</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Applied Science Private University</investigator_affiliation>
    <investigator_full_name>Mahmoud Suleiman Abu-Samak</investigator_full_name>
    <investigator_title>Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics</investigator_title>
  </responsible_party>
  <keyword>Covid -19</keyword>
  <keyword>uninfected</keyword>
  <keyword>IL-1</keyword>
  <keyword>IL-6</keyword>
  <keyword>TNF</keyword>
  <keyword>VDD</keyword>
  <keyword>Vitamin D3</keyword>
  <keyword>50,000IU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytokine Release Syndrome</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>
  <!-- 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/NCT04476745
org study id: 2020-PHA-16
nct id: NCT04476745
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected
      cytokines involved in cytokine storm of Covid-19; A randomized clinical trial in the Covid-19
      uninfected people with vitamin D deficiency.
No data are available on the effect of Weekly 50,000 IU vitamin D3 supplements on the serum
      levels of selected cytokines involved in cytokine storm of Covid-19 in the Covid-19
      uninfected Jordanian people with vitamin D deficiency. This study was designed to investigate
      whether a high dose of vitamin D3 (50,000 IU) / week for 8 weeks supplementation has a
      potential effect on cytokine storm of Covid-19; such as IL-1 beta, IL-6, and TNF in the
      Covid-19 uninfected Jordanian people with vitamin D deficiency.

      This study aims to assess whether high doses of vitamin D3 may improve immune responses
      against COVID-19 infection in uninfected Jordanian peoples. We hypothesize that Weekly 50,000
      IU vitamin D3 supplements will significantly change immune responses compared with the
      control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: IL-1 beta
time frame: 8 weeks
description: seum levels
measure: IL-6
time frame: 8 weeks
description: serum levels
measure: TNF
time frame: 8 weeks
description: serum levels
measure: serum concentrations of 25-hydroxyvitamin D
time frame: 8 weeks
description: ng/ml
measure: lipid profile parameters
time frame: 8 weeks
description: seum levels
arm group label: Experimental: VD3 group
arm group type: Experimental
description: Dietary Supplement: Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks Other Names: cholecalciferol,
arm group label: Control group
arm group type: No Intervention
description: Control group No intervention was given
intervention type: Dietary Supplement
intervention name: Vitamin D3
description: Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
arm group label: Experimental: VD3 group
other name: cholecalciferol
criteria: 
gender: All
minimum age: 30 Years
maximum age: 66 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud S Abu-Samak, PhD
role: Study Chair
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
last name: Dana A Bader, MSc
role: Principal Investigator
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
facility: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: Applied Science Private University
investigator full name: Mahmoud Suleiman Abu-Samak
investigator title: Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics
mesh term: Cytokine Release Syndrome
mesh term: Vitamin D
mesh term: Cholecalciferol