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NCT05458024 · ClinicalTrials.gov registry record · Phase 2
Vitamin D to ENhance TraUma REcovery
A Phase 2 study of Musculoskeletal Pain, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 4
- Study locations
NCT05458024: Completed Phase 2 study of Musculoskeletal Pain, sponsored by University of North Carolina, Chapel Hill.
NCT05458024 is a Phase 2 study of Musculoskeletal Pain that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 71 participants, below the 154-participant average among 37 other Musculoskeletal Pain trials with a reported enrollment target (54% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458024, a Phase 2 study of Musculoskeletal Pain, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Estimates of efficacy will be obtained via repeated measures analysis of pain severity over the 3 months following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as one can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 3 months following motor vehicle collision) will be entered into a linear mixed model, and overall effect estimates (beta coef
Conditions Studied
Interventions
- DRUG Vitamin D 2
- DRUG Vitamin D2 Placebo
Study Locations (4)
Massachusetts
- University of Massachusetts Medical School - Worcester
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Cooper University Hospital - Camden
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2024-05-01 |
| Phase | Phase 2 |
What the finished NCT05458024 record still lists
NCT05458024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 154-participant average among 37 other Musculoskeletal Pain trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Musculoskeletal Pain appearing as the primary indexed condition, and to 2 interventions - of which Vitamin D 2 is the first listed.
NCT05458024 reports a single indexed study location in Massachusetts, Missouri, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05458024 about?
NCT05458024 is a clinical study titled "Vitamin D to ENhance TraUma REcovery". 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 follow...
What is the current status of trial NCT05458024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2023-01-24. Estimated completion is 2024-05-01.
What conditions does trial NCT05458024 study?
This clinical trial studies the following conditions: Musculoskeletal Pain.
What interventions are being tested in trial NCT05458024?
The interventions under investigation include: Vitamin D 2 (DRUG), Vitamin D2 Placebo (DRUG).
Who is sponsoring clinical trial NCT05458024?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05458024 being conducted?
This trial has 4 study locations across Massachusetts, Missouri, New Jersey, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05458024's enrollment target sits among peer trials
71 24th of 37 higher than 14 of 37 other Musculoskeletal Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Musculoskeletal Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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