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

Phase 2

Withdrawn

• Conditions: TBI
• Interventions: Dietary Supplement: Safflower seed oil; Drug: Omega 3 fatty acid

• Registration Number: NCT02990091
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-12
• Study Start: 2017-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-01
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 capsule safflower seed oil	Safflower seed oil	Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
1,000mg/day n-3 HUFA	Omega 3 fatty acid	Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days.
4,000 mg/day n-3 HUFA	Omega 3 fatty acid	Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
4 capsules safflower seed oil	Safflower seed oil	Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.

Primary Outcome Measures

Name	Time	Method
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites	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 Outcome Measures

Name	Time	Method
Evalute potential adverse events	14 days consecutively	Evaluate potential adverse side effects including gastrointestinal tolerance and adverse neurological outcomes.
Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)	14 days consecutively	Clinical outcomes will include functional outcomes and will be assessed by using the TBI Common Data Elements Outcome battery. The analysis will focus on the Glasgow Outcome Scale-Extended (GOS-E) an ordinal scale based on a structured questionnaire which is universally used in TBI clinical studies.

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States