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OPTIMA-TBI Pilot Study

NCT03345550 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-05-23

Study results available
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Summary

This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DRUG

Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.

Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules.

DRUG

Placebo - Cap

Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).

Sponsors & Collaborators

Principal Investigators

  • Frederick Korley, M.D., Ph.D. · Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2021-07-27
Completion
2021-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345550 on ClinicalTrials.gov