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

Not Applicable

Completed

• Conditions: Cytokines; Cytokine Storm
• Interventions: Dietary Supplement: 300 mg of omega3-FA

• Registration Number: NCT04483271
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2020-10-02
• Primary Completion: 2020-12-15
• Study Completion: 2021-02-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
IL-6	(2 months ; 60 days )	pg/ml
IL-1 beta	(2 months ; 60 days )	pg/mL
TNF alpha	(2 months ; 60 days )	pg/ml

Secondary Outcome Measures

Name	Time	Method
Lipid profile	(2 months ; 60 days )	mg/dL
Fasting blood glucose	(2 months ; 60 days )	mg/dl

Trial Locations

Locations (1)

Mahmoud S Abu-Samak; 🇯🇴 Amman, Jordan