Docosahexaenoic Acid (DHA) For The Treatment of Pediatric Concussion Related to Sports Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of Higher Dosage of DHA
研究概览
简要总结
In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play.
Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging.
Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion.
This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.
详细描述
This is a double-blind, randomized, placebo-controlled feasibility trial of DHA for the treatment of pediatric concussion related to sports-injury. The definition used for concussion is from the Consensus Statement on Concussion in Sport: the 3rd International Conference on Concussion in Sport (Br J Sports Med 2009;43:Suppl 1 i76-i84 doi:10.1136/bjsm.2009.058248) and will meet the following criteria:
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Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.
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Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:
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symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability).
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physical signs (eg, loss of consciousness, amnesia).
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behavioural changes (eg, irritability).
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cognitive impairment (eg, slowed reaction times).
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sleep disturbance (eg, drowsiness).
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No abnormality on standard structural neuroimaging studies, if such neuroimaging studies are completed for a clinically-indicated reason. Note: neuroimaging is not a part of this study protocol. Study participants will not undergo neuroimaging as part of this study.
Subjects will be randomized in a 1:1 fashion. DHA is an omega-3 fatty acid that occurs naturally in fish oil and algae. There are many dietary supplements containing DHA available in the marketplace. Martek Biosciences provides an algae-based DHA compound which minimizes the side effects of "fishiness" in both flavor and "fish burps." The DHA produced by Martek Biosciences is also used for many infant formula companies in the US. DHA and identical placebo will be provided by Martek Biosciences.
The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females age 14-18 inclusive
- •Diagnosed with concussion due to sports-related injury. Concussion is defined as:
- •Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.
- •Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:
- •i. Symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog and/or emotional symptoms (eg, lability).
- •ii. Physical signs (eg, loss of consciousness, amnesia).
- •iii. Behavioral changes (eg, irritability).
- •iv. Cognitive impairment (eg, slowed reaction times).
- •v. Sleep disturbance (eg, drowsiness). c) No abnormality on standard structural neuroimaging studies, if such neuroimaging studies are completed for a clinically-indicated reason. Note: neuroimaging is not a part of this study protocol. Study participants will not undergo neuroimaging as part of this study.
- •Concussion within 4 days of enrollment
- •Presenting for treatment to the Sports Medicine Center at Children's Medical Center
排除标准
- •Subjects not actively participating in an organized sport at time of enrollment
- •Subjects who received a concussion from an event other than playing a sport (motor vehicle accident, fall, etc.)
- •Subjects who participate in or received a concussion during participation in motorized sports (i.e., motorcross, dirt biking, jet skiing, etc.)
- •Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture, intracranial hemorrhage, cerebral contusion, etc).
- •Subjects with a prior diagnosed concussion in the previous 6 months.
- •Pregnant women.
- •Subjects sensitive to aspirin
- •Subjects diagnosed with high blood pressure and currently being treated with blood pressure medications
- •Subjects allergic to soy bean oil or corn oil.
- •Subjects currently taking fish oil or DHA supplements.
研究组 & 干预措施
Placebo
The placebo capsules are supplied as 950 mg capsules consisting of 475 mg corn oil and 475 mg soy oil. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the placebo for 12 weeks.
干预措施: Placebo (Drug)
Docosahexaenoic Acid (DHA)
The DHASCO capsules are supplied as 950 mg capsules with an effective dose of 500 mg DHA per capsule. Both DHA and placebo are flavored with sweet orange flavoring and masking agents. Subjects will be instructed to take 2 capsules at breakfast and 2 capsules at dinner (with food). Subjects will take their first dose in the office to assure their ability to swallow the pills. Subjects will be dosed with the DHA for 12 weeks.
干预措施: Docosahexaenoic acid (DHA) (Drug)
结局指标
主要结局
Safety of Higher Dosage of DHA
时间窗: 12 weeks
Determine the safety of a higher dosage of DHA through reported drug-related adverse events during the study period.
次要结局
- Drug Adherence During Study Period(12 weeks)
- Resolution of Balance Impairment(12 weeks)
- Time to Initiation of the Return to Sport (RTS) Progression(12 weeks)
研究者
Shane M. Miller, MD
MD, Associate Professor of Orthopaedics and Pediatrics
University of Texas Southwestern Medical Center