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Vitamin D to ENhance TraUma REcovery

CompletedPhase 2NCT05458024
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Randomized Controlled Trial of Vitamin D to Reduce Racial Disparity in Chronic Pain Following Motor Vehicle Collision
Interventions
  • Drug: Vitamin D 2
  • Drug: Vitamin D2 Placebo
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Start date
2023-01-24
Primary completion
2024-05-01
Sex
All
Age range
from 18 Years to 65 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 \<100 ng/ml * During ED admission pain severity must be at least 4/10 or higher Exclusion Criteria: * 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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05458024