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Omega-3 Fatty Acid Supplement
Fish Oil Capsules for Chronic Traumatic Encephalopathy
N/A
Waitlist Available
Led By Floyd Chilton, Ph.D.
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1) University of Arizona National Collegiate Athletic Association (NCAA) Division I American football athletes cleared to participate in university athletics as determined by the team physician.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; then once a month until the end of the study, up to 8 months.
Awards & highlights
Summary
Determine if the daily docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of American football season among collegiate football athletes.
Eligible Conditions
- Chronic Traumatic Encephalopathy
- Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; then once a month until the end of the study, up to 8 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; then once a month until the end of the study, up to 8 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in brain biomarkers due to sub-concussion injury - Nf-L
Changes in brain biomarkers due to sub-concussion injury - Tau
Changes in brain biomarkers due to sub-concussion injury - UCH-L1
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fish Oil CapsulesExperimental Treatment1 Intervention
Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 3 times a week for 25-weeks during regular football season.
Group II: Safflower Oil CapsulesPlacebo Group1 Intervention
Participants in the treatment arm will receive 3 grams of high-oleic safflower oil) in a 1:1 allocation ratio for 25-weeks during regular football season.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fish Oil (DPA+EPA 2:1 ratio) Capsules
2019
N/A
~40
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Who is running the clinical trial?
University of ArizonaLead Sponsor
529 Previous Clinical Trials
159,143 Total Patients Enrolled
Floyd Chilton, Ph.D.Principal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
20 Total Patients Enrolled
Roberta Brinton, Ph.D.Principal InvestigatorUniversity of Arizona
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