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

NCT02990091 | Withdrawn Phase 2

• 1 other identifier: 826109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  14 days consecutively

• Evalute potential adverse events

  14 days consecutively

Study Arms (4)

1,000mg/day n-3 HUFA

EXPERIMENTAL

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

Drug: Omega 3 fatty acid

4,000 mg/day n-3 HUFA

EXPERIMENTAL

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

Drug: Omega 3 fatty acid

1 capsule safflower seed oil

PLACEBO COMPARATOR

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

Dietary Supplement: Safflower seed oil

4 capsules safflower seed oil

PLACEBO COMPARATOR

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

Dietary Supplement: Safflower seed oil

Interventions

Omega 3 fatty acid DRUG

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.

Also known as: LOVAZA

1,000mg/day n-3 HUFA; 4,000 mg/day n-3 HUFA

Safflower seed oil DIETARY_SUPPLEMENT

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.

1 capsule safflower seed oil; 4 capsules safflower seed oil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3; Omacor

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ramon Diaz-Arrastia, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Presidential Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)