Vitamin D to ENhance TraUma REcovery

NCT05458024 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 21-2589R21MD016467
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Musculoskeletal Pain

Keywords

Vitamin D; Motor Vehicles; Pain; Racial Disparity

Outcome Measures

Primary Outcomes (4)

• Chronic Pain Severity

  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 coefficients) among treatment groups will be determined

  Over 3 months following MVC

• Chronic Pain Race X Treatment Arm Interaction

  Estimates of interaction between race and treatment assignment 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 burn injury) will be entered into a linear mixed model, and the beta coefficient for the race by treatment interaction term will be assessed.

  Over 3 months following MVC

• Enrollment of the 90-participant Sample Size During Enrollment Period (Feasibility)

  One feasibility measure of this study is demonstrating the ability to recruit 90 patients into the trial within 15 months of enrollment of the first participant. Feasibility of enrollment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.

  13 months of enrollment after the first participant

• Percent of Participants Who Are Compliant With Follow-up (Feasibility)

  The primary objective of this study is to ensure that the investigators are able to make follow-up assessments on a majority of participants. The percent of participants who are compliant with follow-up will be determined 3 months following their motor vehicle collision. Feasibility is defined as \>80% of enrolled participants at 3 months following Motor Vehicle Collision (MVC).

  through study completion, 3 months following MVC

Study Arms (2)

Ergocalciferol (Vitamin D2)

ACTIVE COMPARATOR

300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules. These will be given in a single dose prior to discharge from the Emergency Department.

Drug: Vitamin D 2

Ergocalciferol placebo

PLACEBO COMPARATOR

Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU Ergocalciferol capsules administered in the active treatment arm.

Drug: Vitamin D2 Placebo

Interventions

Vitamin D 2 DRUG

300,000 international units (IUs) of Ergocalciferol in 6 50,000 IU capsules.

Also known as: Ergocalciferol 300,000 IU

Ergocalciferol (Vitamin D2)

Vitamin D2 Placebo DRUG

Inert substance will be administered in 6 capsules indistinguishable from the 50,000 IU

Also known as: Ergocalciferol Placebo

Ergocalciferol placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Pain

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

High rate of missing Vitamin D levels at 3-months could impact findings.

Results Point of Contact

• Title: Sam McLean, MD, MPH
• Organization: University of North Carolina at Chapel Hill

samuel_mclean@med.unc.edu

+1 (919) 843-5931

Study Officials

• Samuel McLean

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a blinded study. Investigators, participants, and coordinators will be blinded to the treatment assignment. Active and placebo treatments will be indistinguishable.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized clinical trial enrolling motor vehicle collision survivors within 24 hours after injury (n=90, 45 non-Hispanic Black, and 45 non-Hispanic White) will be randomized in 1:1 allocation of a one-time dose of either Vitamin D or placebo

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: January 24, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months following publication and continuing for 36 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (4)