Randomized Controlled Trial of Vitamin D to reduce racial disparity in chronic pain following Motor Vehicle Collision

维生素 D 的随机对照试验可减少机动车碰撞后慢性疼痛的种族差异

• 批准号: 10473875
• 负责人: SAMUEL A. MCLEAN
• 金额: $ 19.86万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-23 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10473875
• 关键词: Accident and Emergency department; Acute; Acute Pain; Adult; Affect; Aftercare; American; Analgesics; Anti-Inflammatory Agents; Black American; Black Populations; Black race; Burn injury; Chronic; Cohort Studies; Data; Development; Diagnosis; Dose; Emergency Care; Emergency Department evaluation; Ergocalciferols; Event; Fibromyalgia; Goals; Health; Health Care Costs; Home; Hour; Individual; Inflammation; Intervention; Intervention Studies; Intervention Trial; Life; Low Back Pain; Measures; Migraine; Musculoskeletal Pain; National Institute on Minority Health and Health Disparities; Observational Study; Outcome; Outcome Measure; Pain; Pain interference; Participant; Patients; Placebos; Population; Property; Prospective Studies; Protocols documentation; Randomized; Randomized Controlled Trials; Recovery; Reporting; Research; Severities; Survivors; Testing; Time; Trauma; Treatment Efficacy; Vehicle crash; Vitamin D; Whole Blood; Work; base; caucasian American; chronic musculoskeletal pain; chronic pain; cost; critical period; experience; feasibility testing; high risk; improved; pain chronification; pain outcome; pain sensitivity; participant retention; pilot test; pilot trial; prescription opioid; prevent; primary outcome; racial disparity; recruit; socioeconomic disadvantage; socioeconomics; traumatic stress

Project Summary/Abstract: Motor vehicle collisions (MVCs) are one of the most common traumatic stress exposures in the US, and the most common for which individuals seek emergency department (ED) care. More than 1 million Black Americans (Blacks) come to the ED after MVC each year, and >90% of such ED MVC patients are discharged home with a diagnosis of acute musculoskeletal pain (MSP)/strain only. More than 80% of these individuals report acute moderate or severe (mod/sev) MSP in the ED, and >50% of those with acute mod/sev MSP transition to chronic MSP. MVCs, as well as pain after MVC, disproportionately affect Blacks vs. Whites. For example, in our previous cohort studies 67% of Blacks had mod/sev MSP six months after MVC, vs. only 40% of Whites. Interventions are urgently needed that prevent chronic MSP and reduce these MSP outcome disparities. One safe, inexpensive, widely available, and well-tolerated intervention, with exciting potential to achieve these goals, is Vitamin D (Vit D). Vit D insufficiency is much more common in Blacks than Whites. In the Co-PIs’ previous observational study, 77% (103/133) of Black MVC survivors had Vit D insufficiency at the time of ED evaluation. Such low Vit D levels are associated with increased inflammation and worse pain outcomes. Vit D has anti-inflammatory, neuroprotective, and analgesic properties, and Vit D treatment improves pain outcomes in a range of conditions. Results of a recent Vit D intervention study in another trauma population (burn survivors), led by Co-PI Mauck, found that Vit D treatment after burn injury disproportionately improved pain outcomes in Black vs. White burn survivors (67% vs. 33% pain improvement at 6 weeks). Results from a recent analysis performed by the Co-PIs suggest that Vit D administration in the ED after MVC could prevent at least 70,000 Blacks from developing chronic post-MVC MSP annually. The proposed pilot RCT (n=90) will assess the feasibility of administering a long-acting dose of Vit D in the ED to Blacks and Whites presenting within 24 hours of MVC with moderate or severe MSP, along with the ability of this dose to achieve sustained increases in Vit D levels. In addition, the potential efficacy of this intervention to improve MSP outcomes in Blacks and to reduce MSP disparities in Black vs. White MVC survivors will also be evaluated. Participants will be randomized to receive a one-time dose of 300,000 IU Ergocalciferol or placebo; this dose of Ergocalciferol results in Vit D sufficiency for over 3 months. MSP outcomes during the 3 months after MVC will be assessed. This is a critical period in which individuals transition to MSP recovery vs. chronicity. This work leverages Co-PI Mauck’s Vit D expertise and experience conducting Vit D trials, and Co-PI McLean’s experience performing ED-based studies of MVC survivors. Results of this pilot trial will provide the data and experience necessary to submit a large-scale trial (via an NIMHD R01 application) testing the ability of this simple, low cost, safe intervention to prevent chronic MSP and reduce the current marked disparity in chronic MSP outcomes among Black vs. White Americans presenting to the ED after MVC.

项目摘要/摘要： 汽车碰撞（MVC）是美国最常见的创伤应力暴露之一，也是最常见的 个人寻求急诊科（ED）护理的常见。超过100万黑人 （黑人）每年MVC之后来到急诊室，> 90％的ED MVC患者以A出院 仅诊断急性肌肉骨骼疼痛（MSP）/菌株。这些人中有80％以上报告了急性 ED中的中度或重度（MOD/SEV）MSP，急性MOD/SEV MSP转变为慢性的50％ MSP。 MVC以及MVC之后的疼痛，对黑人与白人的影响不成比例。例如，在我们以前的 队列研究67％的黑人在MVC六个月后具有MOD/SEV MSP，而白人仅为40％。干预措施 迫切需要防止慢性MSP并减少这些MSP结果差异。 一种安全，便宜，可用且耐受性良好的干预措施，具有令人兴奋的实现潜力 这些目标是维生素D（VIT D）。 vit d不足在黑人中比白人更普遍。在Co-Pis中 先前的观察性研究，黑色MVC表面的77％（103/133）在ED时具有VIT D不足 评估。如此低的vit d水平与感染增加和疼痛结果较差有关。 vit d 具有抗炎，神经保护性和镇痛特性，VIT D治疗可改善疼痛结果 在各种条件下。最近在另一个创伤人群（烧伤幸存者）的VIT D干预研究的结果， 由Co-Pi Mauck领导，发现烧伤损伤后的VIT D治疗不成比例地改善了疼痛结果 黑色与白色烧伤冲浪者（67％对33％的疼痛在6周时改善）。最近的分析结果 由Co-Pis进行的表明，MVC后ED中的VIT D给药可以预防至少70,000 黑人每年开发慢性MVC MSP。 拟议的试点RCT（n = 90）将评估在施用长效剂量的VIT D的可行性 在MVC 24小时内具有中度或重度MSP的黑人和白色，并具有能力 该剂量以实现持续的vit d水平增加。此外，此干预的潜在效率 为了改善黑人的MSP结果，并减少黑色与白色MVC表面的MSP分布也将 进行评估。参与者将被随机接受300,000 iu Ergocalciferol或安慰剂的一次性剂量； 这种摄取的红核酸剂会导致3个月以上。在三个月中的MSP结果 在评估MVC之后。这是一个关键时期，个人过渡到MSP恢复与慢性性。 这项工作利用了Co-Pi Mauck的VIT D专业知识和进行VIT D试验的经验，以及Co-Pi McLean的 对MVC存活的基于ED的研究的经验。该试验试验的结果将提供数据和 提交大规模试验所需的经验（通过NIMHD R01申请）测试了该试验的能力 简单，低成本，安全的干预，以防止慢性MSP并减少慢性的当前明显差异 在MVC之后向ED展示的黑人与白人美国人之间的MSP结果。