Traumatic Brain Injury Recovery With n-3 Highly Unsaturated Fatty Acids (HUFAs): A Biomarker-driven Approach
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
1,000mg/day n-3 HUFA
Subjects will take one capsule daily starting at study enrollment (within 24 hours of injury) for 14 consecutive days.
干预措施: Omega 3 fatty acid (Drug)
4,000 mg/day n-3 HUFA
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
干预措施: Omega 3 fatty acid (Drug)
1 capsule safflower seed oil
Subjects will take 1 capsule daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
干预措施: Safflower seed oil (Dietary Supplement)
4 capsules safflower seed oil
Subjects will take 2 capsules twice daily starting at enrollment (within 24 hours of injury) for 14 consecutive days.
干预措施: Safflower seed oil (Dietary Supplement)
结局指标
主要结局
Relationship of varying doses of n-3 HUFAs on blood levels of the following bioactive metabolites
时间窗: 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.
次要结局
- Evalute potential adverse events(14 days consecutively)
- Relationship of n-3 HUFA blood levels and clinical outcomes measured by the Glasgow Outcome Scale-Extended (GOSE)(14 days consecutively)
研究者
Ramon Diaz-Arrastia
Presidential Professor
University of Pennsylvania