The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
Primary Purpose
Cytokine Storm, Cytokines
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
300 mg of omega3-FA
Sponsored by
About this trial
This is an interventional prevention trial for Cytokine Storm focused on measuring Covid-19, IL-1 beta, IL-6, TNF alpha, Omega-3, n-3FA, uninfected
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.
Sites / Locations
- Mahmoud S Abu-Samak
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
n-3FA group
Control group
Arm Description
Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months.
No intervention was given
Outcomes
Primary Outcome Measures
IL-1 beta
pg/mL
IL-6
pg/ml
TNF alpha
pg/ml
Secondary Outcome Measures
Lipid profile
mg/dL
Fasting blood glucose
mg/dl
Full Information
NCT ID
NCT04483271
First Posted
July 18, 2020
Last Updated
February 23, 2022
Sponsor
Applied Science Private University
1. Study Identification
Unique Protocol Identification Number
NCT04483271
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science Private University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytokine Storm, Cytokines
Keywords
Covid-19, IL-1 beta, IL-6, TNF alpha, Omega-3, n-3FA, uninfected
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
n-3FA group
Arm Type
Experimental
Arm Description
Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention was given
Intervention Type
Dietary Supplement
Intervention Name(s)
300 mg of omega3-FA
Other Intervention Name(s)
n-3FA
Intervention Description
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.
Primary Outcome Measure Information:
Title
IL-1 beta
Description
pg/mL
Time Frame
(2 months ; 60 days )
Title
IL-6
Description
pg/ml
Time Frame
(2 months ; 60 days )
Title
TNF alpha
Description
pg/ml
Time Frame
(2 months ; 60 days )
Secondary Outcome Measure Information:
Title
Lipid profile
Description
mg/dL
Time Frame
(2 months ; 60 days )
Title
Fasting blood glucose
Description
mg/dl
Time Frame
(2 months ; 60 days )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abu-Samak, PhD
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rafeef A Al-Khaled, MSC
Organizational Affiliation
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud S Abu-Samak
City
Amman
Country
Jordan
12. IPD Sharing Statement
Learn more about this trial
The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
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