Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT01814527
Eligibility Criteria:
Inclusion Criteria:
1. East Carolina University NCAA Division I athlete.
2. Have sustained a concussion within the past 24 hours.
3. A neurological exam not consistent with concern for an intracranial hemorrhage or other significant pathology.
4. Must be at least 18 years old.
Exclusion Criteria:
1. Subjects with a recent prior concussion within the past 30 days.
2. Subjects with a history of moderate to severe TBI that has required hospitalization or resulted in prolonged signs and/or symptoms (\>3 weeks).
3. Subjects with a known neurological diagnosis associated with impaired cognitive function other than Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
4. Subjects already routinely using omega-3/DHA supplementation.
5. Subjects with a known allergy to algae, omega-3 fatty acid, or any component of the formulation.
6. Subjects currently requiring anticoagulants (ie: Warfarin), anti-platelets (ie: aspirin, Plavix) or any Non-steroidal anti-inflammatory drugs (ie: Ibuprofen, Naprosyn).
7. Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 x normal).
8. Subjects with a current lower extremity injury that will affect postural stability testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01814527
Study Brief:
Protocol Section:
NCT01814527