What side effects are associated with this type of intervention?

Omega-3 fatty acid supplementation, used for its anti-inflammatory and neuroprotective effects in treating TBI, is generally well-tolerated. However, some common side effects may include gastrointestinal issues such as diarrhea, nausea, and fishy aftertaste. In rare cases, high doses can lead to increased bleeding risk due to their blood-thinning properties. It is important to consult with a healthcare provider to tailor the treatment to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Traumatic Brain Injury (TBI) that focus on anti-inflammatory and neuroprotective effects similar to omega-3 fatty acid supplementation. Current research is exploring the potential benefits of omega-3 fatty acids in TBI recovery, but further clinical trials are needed to establish efficacy and safety. Other investigational approaches, such as bioactive lipids and specialized pro-resolving mediators (SPMs), are also being studied for their potential in TBI treatment.

What other types of research exist?

Promising novel alternatives to Omega-3 fatty acid supplementation for TBI patients include: 1) Hyperbaric Oxygen Therapy (HBOT), which enhances oxygen delivery to damaged brain tissues and reduces inflammation. 2) Stem Cell Therapy, particularly mesenchymal stem cells, which have shown potential in reducing inflammation and promoting neuronal repair. 3) Neuroprotective peptides like NAP (davunetide), which stabilize microtubules and protect neurons. 4) Anti-inflammatory drugs such as minocycline, which inhibit microglial activation and reduce neuroinflammation. 5) Antioxidant therapies, including N-acetylcysteine (NAC), which combat oxidative stress and support cellular repair mechanisms.

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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

Summary

This trial tests if omega-3 supplements can help adolescents recover faster from a concussion by improving brain cell function and reducing inflammation. Omega-3 fatty acids have shown therapeutic potential in managing concussions and other brain injuries.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum of 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to clinical recovery

Secondary study objectives

Cortisol

Interleukin-6

Pediatric Quality of Life Inventory (Version 4.0) Parents Report

+2 more

Side effects data

From 2019 Phase 4 trial • 69 Patients • NCT01396486

14%

Nausea/Vomit/Diarrhea

Increased Appetite

Cold/Infection/Allergy

Insomnia

Pulmonary

Earache

Thirsty

Neurological

Headache

Tics

Musculoskeletal

Autonomic

Dizzy/Lightheaded

Agitated with Homicidal Statements

100%

80%

60%

40%

20%

Study treatment Arm

Omega-3/Placebo

Omega-3/Inositol

Placebo/Inositol

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) often focus on reducing inflammation and protecting neural tissues. Omega-3 fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are known for their anti-inflammatory and neuroprotective properties. These fatty acids help to modulate inflammatory responses and reduce oxidative stress, which can mitigate secondary brain damage following the initial injury. Additionally, they support membrane fluidity and repair, promoting neuronal survival and function. This is crucial for TBI patients as it can potentially improve recovery outcomes, reduce symptom severity, and enhance overall brain health.