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

基本信息

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
项目类别：
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

项目摘要

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。超过 100 万美国黑人寻求急诊室 (ED) 护理的常见问题。（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为急性肌肉骨骼疼痛 (MSP)/拉伤超过 80% 的人报告为急性疼痛。急诊科中中度或重度 (mod/sev) MSP，并且 >50% 的急性 mod/sev MSP 转为慢性 MSP 以及 MVC 后的疼痛对黑人和白人的影响不成比例。队列研究显示，67% 的黑人在 MVC 六个月后接受了 mod/sev MSP，而白人中只有 40%。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是，维生素 D (Vit D) 不足在黑人中比白人中更为常见。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 不足如此低的维生素 D 水平与炎症增加和维生素 D 恶化有关。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（最近的分析结果显示，6 周后疼痛改善为 67% 与 33%）。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 黑人每年都会从长期的 MVC 后 MSP 发展而来。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，该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 差异参与者将被随机接受一次性剂量 300,000 IU 麦角钙化醇或安慰剂；该剂量的麦角钙化醇可使 MSP 在 3 个月内保持充足的维生素 D。 MVC 后将进行评估，这是个人过渡到 MSP 恢复与慢性的关键时期。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 的研究的经验将提供数据和该试点试验的结果。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。