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临床试验/NCT04483271
NCT04483271已完成不适用

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

Applied Science Private University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
IL-6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria included males and females in the age range of 30-66 years without a medical diagnosis of COVID-19 infection.

排除标准

  • 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.

结局指标

主要结局

IL-6

时间窗: (2 months ; 60 days )

pg/ml

IL-1 beta

时间窗: (2 months ; 60 days )

pg/mL

TNF alpha

时间窗: (2 months ; 60 days )

pg/ml

次要结局

  • Lipid profile((2 months ; 60 days ))
  • Fasting blood glucose((2 months ; 60 days ))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Suleiman Abu-Samak

Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Applied Science Private University

研究点 (1)

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