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The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm

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ClinicalTrials.gov Identifier: NCT04483271
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Suleiman Abu-Samak, Applied Science Private University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cytokine Storm Cytokines Dietary Supplement: 300 mg of omega3-FA Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: n-3FA group
Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months.
Dietary Supplement: 300 mg of omega3-FA

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.

Other Name: n-3FA

No Intervention: Control group
No intervention was given



Primary Outcome Measures :
  1. IL-1 beta [ Time Frame: (2 months ; 60 days ) ]
    pg/mL

  2. IL-6 [ Time Frame: (2 months ; 60 days ) ]
    pg/ml

  3. TNF alpha [ Time Frame: (2 months ; 60 days ) ]
    pg/ml


Secondary Outcome Measures :
  1. Lipid profile [ Time Frame: (2 months ; 60 days ) ]
    mg/dL

  2. Fasting blood glucose [ Time Frame: (2 months ; 60 days ) ]
    mg/dl



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Ages Eligible for Study:   30 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria included males and females in the age range of 30-66 years without a medical diagnosis of COVID-19 infection.

Exclusion Criteria:

  • Exclusion criteria included males or females diagnosed with any chronic immune problems, including autoimmune diseases, chronic or severe infections.
  • Pregnant, breastfeeding, and females using hormonal contraceptives were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483271


Locations
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Jordan
Mahmoud S Abu-Samak
Amman, Jordan
Sponsors and Collaborators
Applied Science Private University
Investigators
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Study Chair: Mahmoud S Abu-Samak, PhD Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Principal Investigator: Rafeef A Al-Khaled, MSC Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
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Responsible Party: Mahmoud Suleiman Abu-Samak, Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University
ClinicalTrials.gov Identifier: NCT04483271    
Other Study ID Numbers: 2020-PHA-18
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Suleiman Abu-Samak, Applied Science Private University:
Covid-19
IL-1 beta
IL-6
TNF alpha
Omega-3
n-3FA
uninfected