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.

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