search
Back to results

Omega-3 Treatment for Concussion in Adolescents (CONCUSS)

Primary Purpose

Concussion, Mild

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Mild focused on measuring Omega-3

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 Supplementation

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pediatric Quality of Life Inventory (Version 4.0) Teen Report
Participants will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Pediatric Quality of Life Inventory (Version 4.0) Parents Report
Parent/guardian will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Sport Concussion Assessment Tool - 5 Symptom Evaluation
Participants will report their symptoms using the post-concussion symptom scale ((PCSS; version from the Sport Concussion Assessment Tool-5) each week until they are determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 132. Higher scores mean worse outcome.
Interleukin-6
Interleukin-6 will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in inflammatory status.
Cortisol
Cortisol will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in stress status.

Full Information

First Posted
April 27, 2023
Last Updated
June 21, 2023
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT05847608
Brief Title
Omega-3 Treatment for Concussion in Adolescents
Acronym
CONCUSS
Official Title
Concussion and Omega-3s - New Consideration for the Therapeutic Use of Nutritional Supplements in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Following mild traumatic brain injury, a neurometabolic cascade occurs with concurrent neuronal disruptions, metabolic changes, excitotoxicity, and changes in cerebral blood flow. Omega-3 fatty acids have been postulated as a possible nutritional supplement which could aid in recovery following a concussion. The omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are derived from alpha-linolenic acid (ALA) which is an essential fatty acid. DHA is present at high concentrations in neuronal cells and contributes to the regulation of cell membranes, neurotransmitter release, neurogenesis, and neuroinflammation. EPA is converted to E-series resolvins which act in an anti-inflammatory manner. Pre-clinical research supports the potential benefits of omega-3 fatty acids following a TBI. There has recently been one pilot study in human adolescents which also supports the need for large randomized controlled trials to fully understand the impact omega-3 fatty acids may have on recovery following concussion. The current evidence suggests that omega-3 supplementation may ameliorate neuroinflammation and neuronal apoptosis, and decrease reactive oxygen species associated with TBI. It has been suggested that following TBI, omega-3 supplementation may improve neural plasticity and signaling related molecules which can improve cognitive function following TBI. Based on these previous mentioned studies it appears that omega-3 fatty acids could potentially benefit those recovering from a concussion. However, to date there have not been any appropriately powered randomized controlled trials evaluating the efficacy of omega-3 supplementation following sport related concussion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild
Keywords
Omega-3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Intervention Description
Daily consumption of 500 mg DHA and 750 mg EPA in liquid form
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Olive Oil
Intervention Description
Oleic Acid, Linoleic Acid
Primary Outcome Measure Information:
Title
Time to clinical recovery
Description
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.
Time Frame
Maximum of 6 weeks
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (Version 4.0) Teen Report
Description
Participants will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Time Frame
Maximum of 6 weeks
Title
Pediatric Quality of Life Inventory (Version 4.0) Parents Report
Description
Parent/guardian will complete the paediatric quality of life inventory (https://www.pedsql.org/index.html) each week until the participant is determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 52. Higher scores mean worse outcome.
Time Frame
Maximum of 6 weeks
Title
Sport Concussion Assessment Tool - 5 Symptom Evaluation
Description
Participants will report their symptoms using the post-concussion symptom scale ((PCSS; version from the Sport Concussion Assessment Tool-5) each week until they are determined to be clinically recovered or have not recovered by 6 weeks. Scale minimum score is 0 and maximum is 132. Higher scores mean worse outcome.
Time Frame
Maximum of 6 weeks
Title
Interleukin-6
Description
Interleukin-6 will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in inflammatory status.
Time Frame
Maximum of 6 weeks
Title
Cortisol
Description
Cortisol will be analyzed via enzyme-linked immunosorbent assay (ELISA) to determine changes in stress status.
Time Frame
Maximum of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Cornish, PhD
Phone
204-474-9981
Email
stephen.cornish@umanitoba.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dean Cordingley, MSc
Phone
204-926-5858
Email
umcordid@myumanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cornish, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Research Centre, Faculty of Kinesiology, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T2N2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Cornish, PhD
Phone
204-474-9981
Email
stephen.cornish@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Stephen Cornish, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Omega-3 Treatment for Concussion in Adolescents

We'll reach out to this number within 24 hrs