<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/NCT04483271</url>
  </required_header>
  <id_info>
    <org_study_id>2020-PHA-18</org_study_id>
    <nct_id>NCT04483271</nct_id>
  </id_info>
  <brief_title>The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm</brief_title>
  <official_title>The Effect of Omega-3 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</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 trial was designed to assess the effect of daily dose of 300 mg omega-3 supplements for 2&#xD;
      months on the selected interleukins levels in uninfected people with Covid-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Omega-3 Fatty Acids (Omega-3) are long poly unsaturated fatty acids that can be found in&#xD;
      plants and fish, its refer to a group composed of three type of fatty acids called:&#xD;
      Eicosapentaenoic acid (EPA), Alpha-linoleic acid (ALA), and Docosahexaenoic acid (DHA) . The&#xD;
      health promoting effect of n-3FA may be due to immune modulating and anti-inflammatory&#xD;
      actions . The anti-inflammatory properties of n-3FA are used for treatment of the&#xD;
      inflammatory diseases such as irritable bowel syndrome, rheumatoid arthritis, eczema, and&#xD;
      psoriasis . Many studies reported a significant reduction in the risk of cancers in breast,&#xD;
      prostate, ovaries with supplementation of n-3FA (Larsson et al. 2004) .However, high-doses&#xD;
      omega-3 supplements such as 1000 mg/day are widely spread in community pharmacies in Jordan .&#xD;
      Currently , community pharmacy around the world are facing the challenge of increased demand&#xD;
      for care of uninfected people with Covid -19. Accordingly , the current randomized clinical&#xD;
      trial was designed to evaluate the effect of daily 300 mg of omega 3-FA supplements on the&#xD;
      immune health status of uninfected people with Covid-19 as a part of as a part of preventive&#xD;
      health care .&#xD;
&#xD;
      Therefore , this RCT aims to assess whether regular daily dose of regular daily dose of omega&#xD;
      3-FA (300 mg) for 2 months supplementation against COVID-19 infection as a part of preventive&#xD;
      treatment protocol in uninfected Jordanian peoples. The investigators hypothesize that the&#xD;
      regular dose of omega 3-FA (300 mg) /day for 2 months will significantly change immune&#xD;
      responses compared with the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-1 beta</measure>
    <time_frame>(2 months ; 60 days )</time_frame>
    <description>pg/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6</measure>
    <time_frame>(2 months ; 60 days )</time_frame>
    <description>pg/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TNF alpha</measure>
    <time_frame>(2 months ; 60 days )</time_frame>
    <description>pg/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipid profile</measure>
    <time_frame>(2 months ; 60 days )</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>(2 months ; 60 days )</time_frame>
    <description>mg/dl</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cytokine Storm</condition>
  <condition>Cytokines</condition>
  <arm_group>
    <arm_group_label>n-3FA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention was given</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>300 mg of omega3-FA</intervention_name>
    <description>The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.&#xD;
Baseline and follow-up serum levels of IL-1,IL-6, and TNF will be measured.</description>
    <arm_group_label>n-3FA group</arm_group_label>
    <other_name>n-3FA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria included males and females in the age range of 30-66 years without&#xD;
             a medical diagnosis of COVID-19 infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria included males or females diagnosed with any chronic immune&#xD;
             problems, including autoimmune diseases, chronic or severe infections.&#xD;
&#xD;
          -  Pregnant, breastfeeding, and females using hormonal contraceptives were also excluded.&#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>Rafeef A Al-Khaled, 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 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 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">February 24, 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>IL-1 beta</keyword>
  <keyword>IL-6</keyword>
  <keyword>TNF alpha</keyword>
  <keyword>Omega-3</keyword>
  <keyword>n-3FA</keyword>
  <keyword>uninfected</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytokine Release Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04483271
org study id: 2020-PHA-18
nct id: NCT04483271
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The trial was designed to assess the effect of daily dose of 300 mg omega-3 supplements for 2
      months on the selected interleukins levels in uninfected people with Covid-19.
Omega-3 Fatty Acids (Omega-3) are long poly unsaturated fatty acids that can be found in
      plants and fish, its refer to a group composed of three type of fatty acids called:
      Eicosapentaenoic acid (EPA), Alpha-linoleic acid (ALA), and Docosahexaenoic acid (DHA) . The
      health promoting effect of n-3FA may be due to immune modulating and anti-inflammatory
      actions . The anti-inflammatory properties of n-3FA are used for treatment of the
      inflammatory diseases such as irritable bowel syndrome, rheumatoid arthritis, eczema, and
      psoriasis . Many studies reported a significant reduction in the risk of cancers in breast,
      prostate, ovaries with supplementation of n-3FA (Larsson et al. 2004) .However, high-doses
      omega-3 supplements such as 1000 mg/day are widely spread in community pharmacies in Jordan .
      Currently , community pharmacy around the world are facing the challenge of increased demand
      for care of uninfected people with Covid -19. Accordingly , the current randomized clinical
      trial was designed to evaluate the effect of daily 300 mg of omega 3-FA supplements on the
      immune health status of uninfected people with Covid-19 as a part of as a part of preventive
      health care .

      Therefore , this RCT aims to assess whether regular daily dose of regular daily dose of omega
      3-FA (300 mg) for 2 months supplementation against COVID-19 infection as a part of preventive
      treatment protocol in uninfected Jordanian peoples. The investigators hypothesize that the
      regular dose of omega 3-FA (300 mg) /day for 2 months will significantly change immune
      responses compared with the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: IL-1 beta
time frame: (2 months ; 60 days )
description: pg/mL
measure: IL-6
time frame: (2 months ; 60 days )
description: pg/ml
measure: TNF alpha
time frame: (2 months ; 60 days )
description: pg/ml
measure: Lipid profile
time frame: (2 months ; 60 days )
description: mg/dL
measure: Fasting blood glucose
time frame: (2 months ; 60 days )
description: mg/dl
arm group label: n-3FA group
arm group type: Experimental
description: Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months.
arm group label: Control group
arm group type: No Intervention
description: No intervention was given
intervention type: Dietary Supplement
intervention name: 300 mg of omega3-FA
description: The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
Baseline and follow-up serum levels of IL-1,IL-6, and TNF will be measured.
arm group label: n-3FA group
other name: n-3FA
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: Rafeef A Al-Khaled, 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