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

• ClinicalTrials.gov Identifier: NCT04483271
• Recruitment Status: Completed
• First Posted: July 23, 2020
• Last Update Posted: February 24, 2022
• Sponsor: Applied Science Private University
• Information provided by (Responsible Party): Mahmoud Suleiman Abu-Samak, Applied Science Private University

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
Cytokine Storm; Cytokines	Dietary Supplement: 300 mg of omega3-FA	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 2, 2020
• Actual Primary Completion Date: December 15, 2020
• Actual Study Completion Date: February 28, 2021

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 Name: n-3FA
No Intervention: Control group; No intervention was given

Outcome Measures

Primary Outcome Measures :

1. IL-1 beta [ Time Frame: (2 months ; 60 days ) ]
   pg/mL
2. IL-6 [ Time Frame: (2 months ; 60 days ) ]
   pg/ml
3. TNF alpha [ Time Frame: (2 months ; 60 days ) ]
   pg/ml

Secondary Outcome Measures :

1. Lipid profile [ Time Frame: (2 months ; 60 days ) ]
   mg/dL
2. Fasting blood glucose [ Time Frame: (2 months ; 60 days ) ]
   mg/dl

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 66 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Jordan

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

More Information

• Responsible Party: Mahmoud Suleiman Abu-Samak, Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics, Applied Science Private University
• ClinicalTrials.gov Identifier: NCT04483271
• Other Study ID Numbers: 2020-PHA-18
• First Posted: July 23, 2020
• Last Update Posted: February 24, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahmoud Suleiman Abu-Samak, Applied Science Private University:

Covid-19; IL-1 beta; IL-6; TNF alpha; Omega-3; n-3FA; uninfected

Additional relevant MeSH terms:

Cytokine Release Syndrome; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock