Vitamin Therapy in Concussion Management: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 主要终点
- PCSI: Post-Concussion Symptom Inventory
研究概览
简要总结
The purpose of this study is to assess the efficacy of vitamin therapy in concussion when compared to placebo with respect to multiple endpoints including symptom severity, cognitive performance on computer based neuropsychological testing, post-concussion balance assessment, and post-concussion vestibular-oculomotor function.
详细描述
To date, very little data exists on the use of vitamin supplementation to aid in the recovery of concussion. Data previously published shows potential benefit of certain vitamins in the management of migraine headache. These vitamins, Vitamin B2 (Riboflavin), Magnesium, Co-Enzyme Q-10, and Omega-3 fatty acids, at dosages described in the literature, are being used based on the migraine literature findings and anecdotal evidence to help treat complaints of headache in concussion management.
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
- 11 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ages 11-22
- •Concussion within 7 days of enrollment
- •Presenting for treatment at Rothman Institute or Jefferson Concussion Center
排除标准
- •Subjects with recent prior concussion within the past 30 days
- •Subjects with a history of moderate to severe TBI requiring hospitalization or resulting in prolonged symptoms (>3weeks).
- •Subjects with known neurologic diagnosis associated with impaired cognitive function other that Attention Deficit Hyperactive Disorder or Attention Deficit Disorder.
- •Subjects with know allergy to algae, omega-3 fatty acid, or any component of the formulation.
- •Subjects currently requiring anticoagulants (ie- Warfarin), anti-platelets (ie- Aspirin, Plavix), or any non-steroidal anti-inflammatory drugs (ie- Ibuprofen, Naprosyn).
- •Subjects with known liver pathology or significantly elevated liver function tests (greater than 3 X normal).
- •Subjects with a current lower extremity injury that will affect postural stability testing.
- •Subjects who are pregnant and/or breast feeding.
结局指标
主要结局
PCSI: Post-Concussion Symptom Inventory
时间窗: 4 weeks
次要结局
未报告次要终点