Clinical trial NCT04483271: The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytokine Storm
Cytokines
Keywords: Covid-19
IL-1 beta
IL-6
TNF alpha
Omega-3
n-3FA
uninfected
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: IL-1 beta
timeFrame: (2 months ; 60 days )
measure: IL-6
timeFrame: (2 months ; 60 days )
measure: TNF alpha
timeFrame: (2 months ; 60 days )
Secondary outcomes:
measure: Lipid profile
timeFrame: (2 months ; 60 days )
measure: Fasting blood glucose
timeFrame: (2 months ; 60 days )
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Mahmoud S Abu-Samak
Study officials:
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
name: Mahmoud S Abu-Samak, PhD
role: STUDY_CHAIR
affiliation: Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
name: Rafeef A Al-Khaled, MSC
role: PRINCIPAL_INVESTIGATOR
References: