Phase 2
N=71
Vitamin D to ENhance TraUma REcovery
Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT05458024 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Chronic Pain Severity — 4.33; 5; 4.39; 4.22 score on a scale — p=0.83
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D 2 (Drug); Vitamin D2 Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Pain Severity |
4.33; 5; 4.39; 4.22; 3.81; 3.92 | 0.83 |
| PRIMARY Chronic Pain Race X Treatment Arm Interaction |
3; 5.91; 4.3; 5.47; 2.69; 6.60 | 0.21 |
| PRIMARY Enrollment of the 90-participant Sample Size During Enrollment Period (Feasibility) |
71 | — |
| PRIMARY Percent of Participants Who Are Compliant With Follow-up (Feasibility) |
66.7; 80.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years and ≤ 65 years of age
- Admitted to ED within 24 hours of motor vehicle collision
- Plan to discharge to home from the emergency department
- Stated willingness to comply with all study procedures and availability for the duration of the study (with the exception of the blood draw sample collected in the ED, which is optional)
- Has a smartphone with continuous service >1 year
- Able to speak and read English
- Alert and oriented, and capable of engaging in informed consent
- Willing to take on-time dose of study medication (6 capsules of Vitamin D or placebo)
- Non-Hispanic white or non-Hispanic black
- Point of care Vitamin D level 20 mg oral daily morphine equivalents)
- Active psychosis, suicidal ideation, or homicidal ideation
- Plans for hospital admission
- Known chronic kidney disease, stage 4 or higher (GFR≤29)
- Intubated and sedated at time of enrollment
- Inability to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)
- Vitamin D supplements in excess of 800 IU daily
- Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)
Data sourced from ClinicalTrials.gov (NCT05458024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.