Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach
Overview
- Phase
- Phase 2
- Intervention
- Omega 3 fatty acid
- Conditions
- TBI
- Sponsor
- University of Pennsylvania
- Locations
- 1
- Primary Endpoint
- Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a Phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 HUFA (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-DHA, and D-series resolvins, on clinical outcomes after TBI.
Investigators
Ramon Diaz-Arrastia
Presidential Professor
University of Pennsylvania
Eligibility Criteria
Inclusion Criteria
- •Documented/ verified TBI
- •Ability to swallow study agent within 48h of injury
- •If a sexually active female who is able to get pregnant, must be already taking birth control (prescription contraception)
- •Visual acuity/ hearing adequate for testing
- •Fluency in English or Spanish
- •Ability to provide informed consent for themselves
- •Co-enrolled in PARC-TBI protocol (IRB protocol #825783) or TRACK-TBI (IRB protocol #825503)
Exclusion Criteria
- •Unstable respiratory or hemodynamic status
- •Evidence of penetrating brain injury
- •Requirement for craniotomy or craniectomy
- •Evidence of serious infectious complications
- •Acute ischemic heart disease or abnormal heart rhythm
- •History of abnormality in liver function
- •History or evidence of active malignancy
- •History of diabetes
- •History of pre-existing neurologic disorder, such as dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe TBI, or other disorder that confounds interpretation neuropsychological results
- •History of pre-existing disabling Axis I psychiatric disorder, such as major depression, schizophrenia, bipolar disorder or dementia
Arms & Interventions
1,000mg/day n-3 HUFA
Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days.
Intervention: Omega 3 fatty acid
4,000 mg/day n-3 HUFA
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Intervention: Omega 3 fatty acid
1 capsule safflower seed oil
Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Intervention: Safflower seed oil
4 capsules safflower seed oil
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
Intervention: Safflower seed oil
Outcomes
Primary Outcomes
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
Time Frame: 14 days consecutively
Bioactive metabolites being looked at are: synaptamide (n-docosahexaenoylethanolamine), 17-hydroxy-DHA, and D-series resolvins and determine relationship of n-3 HUFAs on blood levels of indicators of neuroinflammatory damage including Brain Derived Neurotrophic Factor (BDNF) in humans over 14 days after TBI.
Secondary Outcomes
- Evalute potential adverse events(14 days consecutively)
- Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)(14 days consecutively)