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: 10288662
• 负责人: SAMUEL A. MCLEAN
• 金额: $ 28.02万
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10288662
• 关键词: Accident and Emergency department; Acute; Acute Pain; Adult; Affect; African American; Aftercare; American; Analgesics; Anti-Inflammatory Agents; 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; 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 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.

项目概要/摘要： 机动车碰撞（MVC）是美国最常见的创伤性应激反应之一，也是最常见的创伤性应激反应之一。 常见于个人寻求急诊科（艾德）护理的情况。超过100万美国黑人 （黑人）每年在MVC后来到艾德，并且>90%的这种艾德MVC患者出院回家时具有 仅诊断急性肌肉骨骼疼痛（MSP）/劳损。超过80%的人报告急性 艾德中中度或重度（mod/sev）MSP，以及>50%的急性mod/sev MSP转化为慢性MSP MSP。MVC，以及MVC后的疼痛，不成比例地影响黑人与白人。例如，在我们以前的 队列研究67%的黑人在MVC后6个月有中度/重度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、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 维生素D（Vitamin D）维生素D不足在黑人中比白人更常见。在Co-PI中， 在先前的观察性研究中，77%（103/133）的黑人MVC幸存者在艾德ED时存在维生素D不足 评价如此低的维生素D水平与炎症增加和疼痛结果恶化有关。Vit D 具有抗炎、神经保护和镇痛特性，维生素D治疗可改善疼痛结局 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，烧伤后的维生素D治疗不成比例地改善了 黑人与白色烧伤幸存者（6周时疼痛改善率分别为67%和33%）。最近一项分析的结果 由Co-PI进行的研究表明，MVC后在艾德中给予维生素D可以预防至少70，000例 黑人每年都会患上慢性MVC后MSP。 拟定的试验性RCT（n=90）将评估在受试者中给予长效剂量维生素D的可行性。 艾德对黑人和白人在MVC 24小时内出现中度或重度MSP，沿着能力 以达到维生素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，减少黑人与白色MVC幸存者的MSP差异， 被评价。受试者将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导致维生素D充足超过3个月。3个月期间的MSP成果 MVC将被评估。这是一个关键时期，其中个人过渡到MSP恢复与慢性。 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姆克林的 对MVC幸存者进行基于ED的研究。这项试点试验的结果将提供数据， 提交大规模试验（通过NIMHD R 01申请）所需的经验，以测试这种能力 简单，低成本，安全的干预措施，以防止慢性MSP和减少目前的显着差距，慢性 黑人与白色美国人在MVC后向艾德陈述的MSP结果。