NCT04483271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

July 18, 2020

Last Update Submit

February 23, 2022

Conditions

Cytokine StormCytokines

Keywords

Covid-19IL-1 betaIL-6TNF alphaOmega-3n-3FAuninfected

Outcome Measures

Primary Outcomes (3)

  • IL-1 beta

    pg/mL

    (2 months ; 60 days )

  • IL-6

    pg/ml

    (2 months ; 60 days )

  • TNF alpha

    pg/ml

    (2 months ; 60 days )

Secondary Outcomes (2)

  • Lipid profile

    (2 months ; 60 days )

  • Fasting blood glucose

    (2 months ; 60 days )

Study Arms (2)

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.

Dietary Supplement: 300 mg of omega3-FA

Control group

NO INTERVENTION

No intervention was given

Interventions

300 mg of omega3-FADIETARY_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.

Also known as: n-3FA
n-3FA group

Eligibility Criteria

Age30 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Pregnant, breastfeeding, and females using hormonal contraceptives were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud S Abu-Samak

Amman, Jordan

Location

MeSH Terms

Conditions

Cytokine Release SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mahmoud S Abu-Samak, PhD

    Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

    STUDY CHAIR

  • Rafeef A Al-Khaled, MSC

    Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmoud S Abu-Samak, PhD Study Principal Investigator Department of Clinical Pharmacy and Therapeutics

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 23, 2020

Study Start

October 2, 2020

Primary Completion

December 15, 2020

Study Completion

February 28, 2021

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

JO(1)