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Omega-3 Fatty Acid
Omega-3 for Concussion (CONCUSS Trial)
N/A
Waitlist Available
Led By Stephen Cornish, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum of 6 weeks
Awards & highlights
CONCUSS Trial Summary
This trial tests if omega-3 fatty acids can improve recovery time, quality of life & symptoms of adolescents with a concussion.
Who is the study for?
Adolescents aged 14-17 with a recent sport-related concussion, willing to follow study rules and available for its duration. They must have a normal Glasgow coma scale score (15) and not taken omega-3 supplements recently or have fish allergies. Pregnant individuals or those with severe brain injuries or certain neurological conditions are excluded.Check my eligibility
What is being tested?
This trial is testing if omega-3 fatty acid supplements can speed up recovery after a concussion in teens, improve their quality of life, reduce symptoms, and affect saliva levels of interleukin-6 and cortisol. Participants will be randomly given either omega-3s or a placebo to compare outcomes.See study design
What are the potential side effects?
While the description doesn't specify side effects, typical ones from omega-3 supplements may include fishy burps, upset stomach, nausea, diarrhea; however these are generally mild.
CONCUSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ maximum of 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum of 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to clinical recovery
Secondary outcome measures
Cortisol
Interleukin-6
Pediatric Quality of Life Inventory (Version 4.0) Parents Report
+2 moreSide effects data
From 2019 Phase 4 trial • 69 Patients • NCT0139648614%
Nausea/Vomit/Diarrhea
5%
Increased Appetite
5%
Cold/Infection/Allergy
5%
Insomnia
5%
Pulmonary
5%
Earache
5%
Thirsty
5%
Neurological
5%
Headache
5%
Tics
5%
Musculoskeletal
5%
Autonomic
5%
Dizzy/Lightheaded
5%
Agitated with Homicidal Statements
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omega-3/Placebo
Omega-3/Inositol
Placebo/Inositol
CONCUSS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omega-3 SupplementationExperimental Treatment1 Intervention
This groups will supplement their regular diet with 1 tsp of fish oil containing 1.5 grams combined omega-3 fatty acid (EPA/DHA) supplement in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
This group will supplement their regular diet with 1 tsp olive oil in liquid form on a daily basis until they are recovered or have been enrolled for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3
2012
Completed Phase 4
~1760
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,382 Total Patients Enrolled
Stephen Cornish, PhDPrincipal InvestigatorUniversity of Manitoba
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a sports-related concussion within the last week.I am willing and able to follow all study rules and be available for its duration.I have had a serious brain injury, epilepsy, or stroke.I have had a brain injury confirmed by scans.I am at least 14 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Omega-3 Supplementation
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for participation in this experiment above 25 years?
"This trial is welcoming participants who are age 14 and above, but no more than 17 years of age."
Answered by AI
Am I a suitable candidate to enroll in this medical experiment?
"This clinical trial is recruiting 140 adolescents between the ages of 14 and 17 who have suffered from traumatic brain injury."
Answered by AI
Is this clinical trial presently accepting new participants?
"As indicated on clinicaltrials.gov, recruitment for this medical trial has ceased - with the original posting and last update being June 1st 2023 and April 27th 2023 respectively. However, there are 82 other active studies that can still be registered for by patients."
Answered by AI
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