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： 机动车碰撞 (MVC) 是美国最常见的创伤性压力暴露之一，也是最常见的创伤性压力暴露之一。 个人寻求急诊科 (ED) 护理的常见情况。超过100万美国黑人 （黑人）每年在 MVC 后来到急诊室，>90% 的此类 ED MVC 患者出院回家 仅诊断急性肌肉骨骼疼痛 (MSP)/拉伤。其中超过 80% 的人报告患有严重的 急诊科中中度或重度 (mod/sev) MSP，并且 >50% 的急性 mod/sev MSP 转变为慢性 MSP。 MVC 以及 MVC 后的疼痛对黑人和白人的影响不成比例。例如，在我们之前的 队列研究显示，67% 的黑人在 MVC 六个月后出现 mod/sev MSP，而白人中只有 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、广泛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，就是维生素D（Vit D）。维生素 D 不足在黑人中比白人更常见。在 Co-PI 中 之前的观察性研究显示，77% (103/133) 的黑人 MVC 幸存者在急诊时存在维生素 D 不足 评估。如此低的维生素 D 水平与炎症加剧和疼痛结果恶化有关。维生素D 具有抗炎、神经保护和镇痛特性，维生素 D 治疗可改善疼痛结果 在一系列条件下。最近对另一个创伤人群（烧伤幸存者）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，烧伤后的维生素 D 治疗显着改善了烧伤患者的疼痛结果 黑人与白人烧伤幸存者（6 周后疼痛改善分别为 67% 与 33%）。最近的分析结果 由 Co-PI 进行的研究表明，MVC 后在急诊室施用维生素 D 可以预防至少 70,000 黑人每年都会患上慢性 MVC 后 MSP。 拟议的试点随机对照试验 (n=90) 将评估在人群中施用长效剂量维生素 D 的可行性。 在 MVC 后 24 小时内就诊的患有中度或重度 MSP 的黑人和白人，以及具有以下能力的 ED 该剂量可实现维生素 D 水平的持续增加。此外，这种干预措施的潜在功效 改善黑人的 MSP 结果并减少黑人与白人 MVC 幸存者的 MSP 差异 进行评估。参与者将随机接受一次性剂量 300,000 IU 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，持续 3 个月以上。 3个月内MSP结果 MVC 之后将进行评估。这是个人向 MSP 恢复与长期发展过渡的关键时期。 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。该试点试验的结果将提供数据和 提交大规模试验（通过 NIMHD R01 申请）测试此能力所需的经验 简单、低成本、安全的干预措施可预防慢性 MSP 并缩小目前慢性 MSP 的明显差距 MVC 后向急诊科提交的美国黑人与白人的 MSP 结果。