Clinical trial NCT02990091: Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury
Official title: Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: TBI
Keywords: TBI
DHA
omega-3 highly unsaturated fatty acids
synaptamide
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Age 18-55
2. Documented/ verified TBI
3. Ability to swallow study agent within 48h of injury
4. If a sexually active female who is able to get pregnant, must be already taking birth control (prescription contraception)
5. Visual acuity/ hearing adequate for testing
6. Fluency in English or Spanish
7. Ability to provide informed consent for themselves
8. Co-enrolled in PARC-TBI protocol (IRB protocol #825783) or TRACK-TBI (IRB protocol #825503)
9. GCS 13-15

Exclusion Criteria:

1. Unstable respiratory or hemodynamic status
2. Evidence of penetrating brain injury
3. Requirement for craniotomy or craniectomy
4. Evidence of serious infectious complications
5. Acute ischemic heart disease or abnormal heart rhythm
6. History of abnormality in liver function
7. History or evidence of active malignancy
8. History of diabetes
9. 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
10. History of pre-existing disabling Axis I psychiatric disorder, such as major depression, schizophrenia, bipolar disorder or dementia
11. Allergy to omega-3 fatty acid ethyl esters or any ingredient of the study agent.
12. Known allergy to Safflower seed oil or ragweed plants
13. Consumption of fish or seafood 3 or more times per week on average or regular administration of omega-3 supplements (e.g., cod liver oil, borage oil, fish oil or evening primrose oil) defined as an average of 250 mg/day of n-3 HUFAs, over the previous 3 months.
14. Pregnancy or breast-feeding
15. Prisoners or patients in custody
16. Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish.
17. Use of anticoagulant medications or aspirin more than once per week within the last three months
18. Enrollment in any concurrent research protocols that would interfere with participant safety or research data integrity.

Primary outcomes:
measure: Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
timeFrame: 14 days consecutively
Secondary outcomes:
measure: Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)
timeFrame: 14 days consecutively
measure: Evalute potential adverse events
timeFrame: 14 days consecutively
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ramon Diaz-Arrastia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: