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

Cytokine Storm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483271
• Other study ID #: 2020-PHA-18
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2022
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cytokine Release Syndrome
• Cytokine Storm
• Cytokines

Intervention

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.

Locations

Country	Name	City	State
Jordan	Mahmoud S Abu-Samak	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-1 beta	pg/mL	(2 months ; 60 days )
Primary	IL-6	pg/ml	(2 months ; 60 days )
Primary	TNF alpha	pg/ml	(2 months ; 60 days )
Secondary	Lipid profile	mg/dL	(2 months ; 60 days )
Secondary	Fasting blood glucose	mg/dl	(2 months ; 60 days )