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激暴露之一，也是 个人寻求急诊科(ED)治疗的常见疾病。100多万美国黑人 (黑人)每年在MVC后来到急诊室，这样的ED MVC患者中有90%出院时带着 仅诊断急性肌肉骨骼疼痛(MSP)/劳损。其中超过80%的人报告说 中重度(MOD/SEV)MSP在ED中，50%的急性MOD/SEV MSP转变为慢性 MSP。MVC以及MVC后的痛苦，对黑人和白人的影响不成比例。例如，在我们之前的 队列研究67%的黑人在MVC术后6个月患有MOD/SEV MSP，而白人只有40%。干预措施 迫切需要预防慢性MSP并减少这些MSP结果差异。 一种安全、廉价、可广泛使用和耐受性良好的干预措施，具有令人兴奋的潜力 这些目标，就是维生素D(VitD)。维生素D不足在黑人中比白人中更常见。在合作伙伴关系中 先前的观察性研究显示，77%(103/133)的黑人MVC幸存者在ED时有维生素D不足 评估。如此低的维生素D水平与炎症增加和更糟糕的疼痛结局有关。维生素D 具有抗炎、神经保护和止痛特性，维生素D治疗可改善疼痛结果 在一系列条件下。最近在另一个创伤人群(烧伤幸存者)中进行的维生素D干预研究的结果， 由Co-Pi Mauck领导的研究发现，烧伤后维生素D治疗显著改善了患者的疼痛结果 黑人和白人烧伤幸存者(67%对33%的疼痛改善在6周)。最近一项分析的结果 由Co-Pis进行的研究表明，MVC后ED中的维生素D管理可以防止至少70,000， 黑人每年都会患上MVC后慢性MSP。 拟议的试验性随机对照试验(n=90)将评估长效剂量维生素D在 对患有中度或重度MSP的MVC患者在24小时内出现的黑人和白人ED，以及 以实现维生素D水平的持续增加。此外，这种干预的潜在效果 为了改善黑人的MSP结果并减少黑人与白人的MSP差异，MVC幸存者还将 被评估。参与者将被随机接受一次性剂量为300000国际单位的麦角钙化醇或安慰剂； 此剂量的麦角钙化醇可使维生素D充足3个月以上。MSP在3个月内的结果 之后将对MVC进行评估。这是个体向MSP恢复期与慢性期过渡的关键时期。 这项工作利用了Co-Pi Mauck的维生素D专业知识和进行维生素D试验的经验，以及Co-Pi McLean的 对MVC幸存者进行基于ED的研究的经验。这项试点试验的结果将提供数据和 提交大规模试用(通过NIMHD R01应用程序)以测试以下功能所需的经验 简单、低成本、安全的干预措施，预防慢性MSP，缩小目前慢性MSP的显著差距 美国黑人和白人在MVC后向ED提交MSP结果。