The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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 Names:
|
| No Intervention: Control group No intervention was given |
Outcome Measures
Primary Outcome Measures
- IL-1 beta [(2 months ; 60 days )]
pg/mL
- IL-6 [(2 months ; 60 days )]
pg/ml
- TNF alpha [(2 months ; 60 days )]
pg/ml
Secondary Outcome Measures
- Lipid profile [(2 months ; 60 days )]
mg/dL
- Fasting blood glucose [(2 months ; 60 days )]
mg/dl
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mahmoud S Abu-Samak | Amman | Jordan |
Sponsors and Collaborators
- Applied Science Private University
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-PHA-18