Omega-3 Treatment for Concussion in Adolescents

NCT05847608 | Unknown

• 1 other identifier: B2023:018
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test omega-3 fatty acid supplementation as a treatment in adolescents with a concussion. The main questions it aims to answer are:

• Does supplementing with omega-3 fatty acids improve time to recovery following sport related concussion.
• Does supplementing with omega-3 fatty acids improve health related quality of life following concussion.
• Does supplementing with omega-3 fatty acids change post-concussion symptoms following concussion.
• Does supplementing with omega-3 fatty acids change saliva concentrations of interleukin-6 following concussion.
• Does supplementing with omega-3 fatty acids change saliva concentrations of cortisol following concussion. Participants will be randomized to receive either an omega-3 supplement or placebo after they have been diagnosed with a concussion. Researchers will compare the omega-3 supplement group and placebo group to see if omega-3 fatty acids, consumed as a treatment, can improve time to recovery, health related quality of life and symptom burden, and whether omega-3 fatty acids alter interleukin-6 and cortisol concentrations in saliva following a concussion.

Conditions

Concussion, Mild

Keywords

Omega-3

Outcome Measures

Primary Outcomes (1)

• Time to clinical recovery

  Time to clinical recovery will be determined by the patients treating physician. This will be defined as: 1) symptoms have returned to baseline or resolved, 2) normal medical examination, 3) tolerating school full-time without symptoms, and 4) tolerating appropriate return to play steps and are cleared to participate in full sport activities.

  Maximum of 6 weeks

Secondary Outcomes (5)

• Pediatric Quality of Life Inventory (Version 4.0) Teen Report

  Maximum of 6 weeks

• Pediatric Quality of Life Inventory (Version 4.0) Parents Report

  Maximum of 6 weeks

• Sport Concussion Assessment Tool - 5 Symptom Evaluation

  Maximum of 6 weeks

• Interleukin-6

  Maximum of 6 weeks

• Cortisol

  Maximum of 6 weeks

Study Arms (2)

Omega-3 Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

Daily consumption of 500 mg DHA and 750 mg EPA in liquid form

Also known as: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

Omega-3 Supplementation

Placebo DIETARY_SUPPLEMENT

Oleic Acid, Linoleic Acid

Also known as: Olive Oil

Placebo

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Provide a signed and dated informed consent form;
• State their willingness to comply with all study procedures and availability for the duration of the study;
• Be between 14 and 17 years of age or older;
• Meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 5th Annual Conference of Concussion in Sport, 2017 as determined by the treating physician;
• Present with a sport related concussion within 7 days from injury; and
• Assigned a Glasgow coma scale (GCS) score = 15.

You may not qualify if:

• Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke;
• Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage or cerebral contusion on previous neuro-imaging studies;
• Pregnant patients;
• Patients with a GCS score less than or equal to 14;
• Patients for whom parental/guardian consent cannot be obtained;
• Patients who have consumed an omega-3 fatty acid containing supplement within the past month;
• Patients with a fish or shell fish allergy.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Docosahexaenoic Acids; Eicosapentaenoic Acid; Olive Oil

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Eicosanoids; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephen Cornish, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Cornish, PhD

CONTACT

204-474-9981; stephen.cornish@umanitoba.ca

Dean Cordingley, MSc

CONTACT

204-926-5858; umcordid@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)