Vitamin D to ENhance TraUma REcovery

Completed · Phase 2 · Has a placebo group

Conditions studied: Musculoskeletal Pain

In brief

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.

Key facts

Study ID

NCT05458024

Run by

University of North Carolina, Chapel Hill

People needed

71

Starts

2023-01-24

Expected to finish

2024-05-01

Last updated by the study team

2025-03-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 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 <100 ng/ml
• During ED admission pain severity must be at least 4/10 or higher

You may not qualify if…

• Substantial comorbid injury (e.g., long bone fracture)
• Pregnancy/breastfeeding
• Prisoner status
• Chronic daily opioid use prior to MVC (>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)

Where it is running

• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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