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

TBI Clinical Trial

Official title:

Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02990091
• Other study ID #: 826109
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI

Intervention

Drug:
• Omega 3 fatty acid
LOVAZA is an FDA approved drug that is lawfully marketed in the United States by GlaxoSmithKline. There is no intent to use the results of this study to support a change in the labeling or the advertising of the drug. The highest dose administered for the study is the recommended prescribed dose of LOVAZA, therefore not creating greater risk. The patient population and route of administration will not significantly increase the risk associated with the use of the product. We will be using this drug under an IND exemption.

Dietary Supplement:
• Safflower seed oil
Safflower seed oil is a commonly used dietary supplement. It has been chosen to be used as a comparative to the LOVAZA because of its non-omega-3 fats. There will be no increased risk due to dosage, route of administration, or patient population.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites	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.	14 days consecutively
Secondary	Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)	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.	14 days consecutively
Secondary	Evalute potential adverse events	Evaluate potential adverse side effects including gastrointestinal tolerance and adverse neurological outcomes.	14 days consecutively