Derivatives of Omega-3 HUFA as Biomarkers of Traumatic Brain Injury

University of Pennsylvania

Status and phase: Withdrawn; Phase 2

Conditions: TBI

Treatments: Drug: Omega 3 fatty acid; Dietary Supplement: Safflower seed oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02990091

826109

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 4 patient groups, including a placebo group

1,000mg/day n-3 HUFA

Experimental group

Description:

Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days.

Treatment:

Drug: Omega 3 fatty acid

4,000 mg/day n-3 HUFA

Experimental group

Description:

Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.

Treatment:

Drug: Omega 3 fatty acid

1 capsule safflower seed oil

Placebo Comparator group

Description:

Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.

Treatment:

Dietary Supplement: Safflower seed oil

4 capsules safflower seed oil

Placebo Comparator group

Description:

Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.

Treatment:

Dietary Supplement: Safflower seed oil