Cytokine StormNCT04483271
The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm
A study testing 300 mg of omega3-FA in people with Cytokine Storm and Cytokines, run by Applied Science Private University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytokine Storm, Cytokines
- What is being tested?
- 300 mg of omega3-FA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 2 Oct 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria included males and females in the age range of 30-66 years without a medical diagnosis of COVID-19 infection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cytokine Storm, Cytokines
- Being tested
- 300 mg of omega3-FA
- Keywords
- Covid-19, IL-1 beta, IL-6, TNF alpha, Omega-3, n-3FA, uninfected
- Medical subject headings
- Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg of omega3-FADietary supplement
Also called n-3FA
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.
| Study group | Role | What they receive |
|---|---|---|
| n-3FA group | Experimental | Dietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months. Receives: Dietary Supplement: 300 mg of omega3-FA |
| Control group | No intervention | No intervention was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-1 beta
pg/mL
Measured: (2 months ; 60 days )
IL-6
pg/ml
Measured: (2 months ; 60 days )
TNF alpha
pg/ml
Measured: (2 months ; 60 days )
Secondary outcomes (2)
Lipid profile
mg/dL
Measured: (2 months ; 60 days )
Fasting blood glucose
mg/dl
Measured: (2 months ; 60 days )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start2 Oct 2020
- Primary completion15 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine StormStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Suleiman Abu-Samak, Applied Science Private University
- Investigators
- Mahmoud S Abu-Samak, PhD, Study chair, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -JordanRafeef A Al-Khaled, MSC, Principal investigator, Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483271
- Sponsor's protocol ID
- 2020-PHA-18
- Status last verified
- Feb 2022
- First submitted
- 18 Jul 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04483271
- Acronym / sponsor ID
- 2020-PHA-18
- Conditions
- Cytokine Storm, Cytokines
- Keywords
- Covid-19, IL-1 beta, IL-6, TNF alpha, Omega-3, n-3FA, uninfected
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3FA group | Experimental | Dietary Supplement: 300 mg of omega3-FADietary Supplement: 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA for 2 months. |
| Control group | No intervention | –No intervention was given |
Who may qualify
- Ages
- 30 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included males and females in the age range of 30-66 years without a medical diagnosis of COVID-19 infection.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 300 mg of omega3-FAAlso: n-3FAThe 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. | Dietary supplement | n-3FA group |
Primary outcome
IL-1 beta
Time frame: (2 months ; 60 days )
pg/mL
IL-6
Time frame: (2 months ; 60 days )
pg/ml
TNF alpha
Time frame: (2 months ; 60 days )
pg/ml
2 secondary outcomes
Lipid profile
Time frame: (2 months ; 60 days )
Fasting blood glucose
Time frame: (2 months ; 60 days )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S Abu-Samak, PhD study chair
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
Rafeef A Al-Khaled, MSC principal investigator
Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 mg of omega3-FA in people with Cytokine Storm and Cytokines, run by Applied Science Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-1 beta (time frame: (2 months ; 60 days )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.