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:10288662
- 负责人:
- 金额:$ 28.02万
- 依托单位:
- 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 2023-04-30
- 项目状态:已结题
- 来源:
- 关键词:Accident and Emergency departmentAcuteAcute PainAdultAffectAfrican AmericanAftercareAmericanAnalgesicsAnti-Inflammatory AgentsBurn injuryChronicCohort StudiesDataDevelopmentDiagnosisDoseEmergency CareEmergency Department evaluationErgocalciferolsEventFibromyalgiaGoalsHealthHealth Care CostsHomeHourIndividualInflammationInterventionIntervention StudiesIntervention TrialLifeLow Back PainMeasuresMigraineMusculoskeletal PainObservational StudyOutcomeOutcome MeasurePainPain interferenceParticipantPatientsPlacebosPopulationPropertyProspective StudiesProtocols documentationRandomizedRandomized Controlled TrialsRecoveryReportingResearchSeveritiesSurvivorsTestingTimeTraumaTreatment EfficacyVehicle crashVitamin DWhole BloodWorkbasecaucasian Americanchronic musculoskeletal painchronic paincostcritical periodexperiencefeasibility testinghigh riskimprovedpain chronificationpain outcomepain sensitivityparticipant retentionpilot trialprescription opioidpreventprimary outcomeracial disparityrecruitsocioeconomic disadvantagesocioeconomicstraumatic 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.
项目总结/文摘:
项目成果
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{{ truncateString('SAMUEL A. MCLEAN', 18)}}的其他基金
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 - 财政年份:2021
- 资助金额:
$ 28.02万 - 项目类别:
Influence of PTSD Symptoms on Chronic Pain Development after Sexual Assault
PTSD 症状对性侵犯后慢性疼痛发展的影响
- 批准号:
9349461 - 财政年份:2014
- 资助金额:
$ 28.02万 - 项目类别:
Applying Biopsychosocial Model to Post-MVC Pain Development in African Americans
将生物心理社会模型应用于非裔美国人 MVC 后疼痛的发展
- 批准号:
8916916 - 财政年份:2014
- 资助金额:
$ 28.02万 - 项目类别:
Influence of PTSD Symptoms on Chronic Pain Development after Sexual Assault
PTSD 症状对性侵犯后慢性疼痛发展的影响
- 批准号:
8893895 - 财政年份:2014
- 资助金额:
$ 28.02万 - 项目类别:
Influence of PTSD Symptoms on Chronic Pain Development after Sexual Assault
PTSD 症状对性侵犯后慢性疼痛发展的影响
- 批准号:
8630698 - 财政年份:2014
- 资助金额:
$ 28.02万 - 项目类别:
Influence of PTSD Symptoms on Chronic Pain Development after Sexual Assault
PTSD 症状对性侵犯后慢性疼痛发展的影响
- 批准号:
9101975 - 财政年份:2014
- 资助金额:
$ 28.02万 - 项目类别:
Applying Biopsychosocial Model to Post-MVC Pain Development in African Americans
将生物心理社会模型应用于非裔美国人 MVC 后疼痛的发展
- 批准号:
8683850 - 财政年份:2013
- 资助金额:
$ 28.02万 - 项目类别:
Applying Biopsychosocial Model to Post-MVC Pain Development in African Americans
将生物心理社会模型应用于非裔美国人 MVC 后疼痛的发展
- 批准号:
8722313 - 财政年份:2011
- 资助金额:
$ 28.02万 - 项目类别:
Applying Biopsychosocial Model to Post-MVC Pain Development in African Americans
将生物心理社会模型应用于非裔美国人 MVC 后疼痛的发展
- 批准号:
8912983 - 财政年份:2011
- 资助金额:
$ 28.02万 - 项目类别:
Applying Biopsychosocial Model to Post-MVC Pain Development in African Americans
将生物心理社会模型应用于非裔美国人 MVC 后疼痛的发展
- 批准号:
8532639 - 财政年份:2011
- 资助金额:
$ 28.02万 - 项目类别:
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