The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
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|ClinicalTrials.gov Identifier: NCT04483271|
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : February 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cytokine Storm Cytokines||Dietary Supplement: 300 mg of omega3-FA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 15, 2020|
|Actual Study Completion Date :||February 28, 2021|
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
- IL-1 beta [ Time Frame: (2 months ; 60 days ) ]pg/mL
- IL-6 [ Time Frame: (2 months ; 60 days ) ]pg/ml
- TNF alpha [ Time Frame: (2 months ; 60 days ) ]pg/ml
- Lipid profile [ Time Frame: (2 months ; 60 days ) ]mg/dL
- 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|
- Inclusion criteria included males and females in the age range of 30-66 years without a medical diagnosis of COVID-19 infection.
- 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.
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
|Mahmoud S Abu-Samak|
|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|
|Responsible Party:||Mahmoud Suleiman Abu-Samak, Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University|
|Other Study ID Numbers:||
|First Posted:||July 23, 2020 Key Record Dates|
|Last Update Posted:||February 24, 2022|
|Last Verified:||February 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cytokine Release Syndrome
Systemic Inflammatory Response Syndrome