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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cytokine Storm, Cytokines

Intervention / Treatment
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* Dietary Supplement: 300 mg of omega3-FA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-3FA group<br>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<br>* 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.<br>* Other names: n-3FA;|
| No Intervention: Control group<br>No intervention was given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-1 beta | pg/mL | (2 months ; 60 days ) | 
| IL-6 | pg/ml | (2 months ; 60 days ) | 
| TNF alpha | pg/ml | (2 months ; 60 days ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | mg/dL | (2 months ; 60 days ) | 
| Fasting blood glucose | mg/dl | (2 months ; 60 days ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, IL-1 beta, IL-6, TNF alpha, Omega-3, n-3FA, uninfected