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

Primary Purpose

TBI

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omega 3 fatty acid

Safflower seed oil

About this trial

This is an interventional diagnostic trial for TBI focused on measuring TBI, DHA, omega-3 highly unsaturated fatty acids, synaptamide

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-55
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)
GCS 13-15

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
Allergy to omega-3 fatty acid ethyl esters or any ingredient of the study agent.
Known allergy to Safflower seed oil or ragweed plants
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.
Pregnancy or breast-feeding
Prisoners or patients in custody
Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish.
Use of anticoagulant medications or aspirin more than once per week within the last three months
Enrollment in any concurrent research protocols that would interfere with participant safety or research data integrity.

Sites / Locations

Penn Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

1,000mg/day n-3 HUFA

4,000 mg/day n-3 HUFA

1 capsule safflower seed oil

4 capsules safflower seed oil

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Evalute potential adverse events

Evaluate potential adverse side effects including gastrointestinal tolerance and adverse neurological outcomes.

Full Information

NCT ID

NCT02990091

First Posted

December 5, 2016

Last Updated

October 10, 2022

Sponsor

University of Pennsylvania

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT02990091

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit participants

Study Start Date

January 2017 (undefined)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TBI

Keywords

TBI, DHA, omega-3 highly unsaturated fatty acids, synaptamide

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1,000mg/day n-3 HUFA

Arm Type

Experimental

Arm Description

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

Arm Title

4,000 mg/day n-3 HUFA

Arm Type

Experimental

Arm Description

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

Arm Title

1 capsule safflower seed oil

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

4 capsules safflower seed oil

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omega 3 fatty acid

Other Intervention Name(s)

LOVAZA

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Safflower seed oil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites

Description

Time Frame

14 days consecutively

Secondary Outcome Measure Information:

Title

Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)

Description

Time Frame

14 days consecutively

Title

Evalute potential adverse events

Description

Evaluate potential adverse side effects including gastrointestinal tolerance and adverse neurological outcomes.

Time Frame

14 days consecutively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-55 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) GCS 13-15 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 Allergy to omega-3 fatty acid ethyl esters or any ingredient of the study agent. Known allergy to Safflower seed oil or ragweed plants 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. Pregnancy or breast-feeding Prisoners or patients in custody Allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish. Use of anticoagulant medications or aspirin more than once per week within the last three months Enrollment in any concurrent research protocols that would interfere with participant safety or research data integrity.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramon Diaz-Arrastia, MD, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn Presbyterian Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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