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

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

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.

Study Overview

• Status: Completed
• Conditions: Cytokine Storm; Cytokines
• Intervention / Treatment: Dietary supplement: 300 mg of omega3-FA

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Mahmoud S Abu-Samak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: n-3FA
No Intervention: Control group; No intervention was given

What is the study measuring?

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 )

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19; IL-1 beta; IL-6; TNF alpha; Omega-3; n-3FA; uninfected
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Cytokine Release Syndrome
• Other Study ID Numbers: 2020-PHA-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No