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Completed

NCT Number: NCT04483271

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

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.

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Key information

Conditions

Cytokine Storm COVID-19 Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Cytokines Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Shock Systemic Inflammatory Response Syndrome Virus Diseases

Age range

30 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud S Abu-Samak

Amman, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300 mg of omega3-FA

Dietary Supplement

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

Primary outcomes

  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 outcomes

  1. Lipid profile

    Time frame: (2 months ; 60 days )

    mg/dL

  2. Fasting blood glucose

    Time frame: (2 months ; 60 days )

    mg/dl

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 23, 2020
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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