Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05458024 |
| Other study ID # |
21-2589 |
| Secondary ID |
R21MD016467 |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
December 8, 2022 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
University of North Carolina, Chapel Hill |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of this study is to determine whether the administration of a single dose
of Vitamin D in the Emergency Department following a motor vehicle collision can improve
musculoskeletal pain severity as well as reduce musculoskeletal pain outcome disparity
between Blacks and White following a motor vehicle collision. This randomized controlled
trial is a pilot study to determine feasibility and potential efficacy (response to study
drug, ability to reduce racial disparity in pain outcomes). This data can be used to
adequately power a larger randomized controlled trial to fully assess efficacy.
Description:
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 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 (Vitamin D). The dose of Ergocalciferol that
the investigators propose, 300,000 IU, has been shown to effectively raise Vitamin D
concentration by ~9 ng/ml, and to raise serum 25 hydroxyvitamin D concentration above 30
ng/ml (Vitamin D sufficient levels) for over 3 months5. The ability of this single-dose
protocol to raise Vitamin D will be a primary feasibility endpoint of this pilot study.
Importantly, this dose is extremely well-tolerated: in previous trials, reports of side
effects/adverse events is rare,6 many studies administering single, high-dose regimens report
no side effects7-9, and the most common side effects have been mild GI complaints (e.g.
nausea).6 Vitamin D administration has also been demonstrated to be safe, even among
individuals who are already Vitamin D sufficient. 10-12
Chronic pain is associated with reduced mental and physical health and interferes with
essential activities of daily life. Currently there are limited treatment options to address
chronic pain once it has become established and the overarching aim of this clinical trial is
to prevent chronic pain development, therefore there is a critical unmet need of safe,
non-addictive, non-invasive preventative treatment options that can be administered to MVC
survivors in the aftermath of an injury. This study has the potential to benefit participants
and future MVC survivors and improve pain and general health outcomes. The risks of taking
Vitamin D are small. Side effects from Vitamin D are rare, however, it is possible that over
supplementation of Vitamin D may be associated with headache, loss of appetite, dry mouth,
metallic taste, and nausea/vomiting.
Primary Objective:
1. Assess the feasibility of the RCT protocol by (a) calculating recruitment rate and
participant retention, and (b) measuring the ability of Vitamin D administration to
generate sustained increases in whole-blood Vitamin D concentrations (assessed 3 months
after MVC).
2. To demonstrate the preliminary efficacy of Vitamin D administration per protocol on
decreasing overall MSP severity during the 3 months following MVC, and reducing MSP
outcome disparity between Blacks and Whites following MVC.
Secondary Objectives:
The investigators will assess the effect of race and sex on treatment outcomes in secondary
analyses. This will be accomplished using two analytic strategies. First, a sex X treatment
interaction term (secondary analyses) will be entered into the statistical models to assess
pain reduction in response to treatment. Second, a stratified analysis will be performed
which will examine the influence of both sex and race on treatment effect on primary and
secondary outcomes. Further, Secondary stratified analyses evaluate the influence of initial
vitamin D level on treatment response. In addition, exploratory analyses on the relationship
of vitamin D outcome and trajectory of pain as well as restricting analyses to participants
with vitamin D deficiency at baseline will be performed. Secondary analyses will examine
treatment effects adjusting for any baseline differences in psychosocial factors between
treatment arms.
Long-Term Aims Beyond the Present Proposal:
To use data collected to design and adequately power a larger-scale RCT assessing the
efficacy of Vitamin D treatment in decreasing chronic pain in high-risk patients presenting
for treatment in the aftermath of MVC and to reduce racial disparity in pain outcomes
following MVC.
Described the sequence of events in recruiting 90 patients in a multi-center randomized
controlled trial. To assess a key primary outcome, 50% white and 50% black MVC will be
enrolled into the study. Each participant will be screened in based on a point of care
Vitamin D test. This will be performed at the time of screening. Individuals with a Vitamin D
level <100 ng/ml will be enrolled. Patients will be randomized 1:1 to receive a single dose
of 300,000 IU of ergocalciferol versus placebo and followed for 3 months. At 3 months,
patients will send a blood sample easily collected at home on a blood spot card to assess
Vitamin D level 3 months following injury which is a key feasibility primary outcome.
Patients presenting to the ED within 24 hours of MVC (n=90, 45 non-Hispanic Black, and 45
non-Hispanic White) will receive a single dose of study drug prior to ED discharge (1:1
allocation 300,000 IU ergocalciferol or placebo). Prior to study drug administration, a
baseline assessment will be performed (see below), and a fingerstick blood sample will be
obtained to evaluate 25-hydroxyvitamin D level. Telephone follow-ups assessing primary and
secondary outcomes and potential adverse events will be performed 3 weeks, 6 weeks, and 3
months after ED enrollment by study Research Assistants using web-based REDCap™ software. At
3 months, participants will also perform fingerstick blood collection at home and mail to the
study team to enable assessment of 3 month 25-hydroxyvitamin D concentration by treatment
group.
