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Vitamin

Vitamin D for Musculoskeletal Pain (VENTURE Trial)

Phase 2

Waitlist Available

Led By Matt Mauck

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months of enrollment the first participant

Awards & highlights

VENTURE Trial Summary

This trial is testing whether giving Vitamin D to people who have been in a car crash can improve their muscle pain and reduce differences in pain outcomes between Black and White people.

Who is the study for?

This trial is for non-Hispanic white or black adults aged 18-65 who've been in a car accident within the last 24 hours, have significant pain (4/10 or more), and low Vitamin D levels. They must own a smartphone, speak English, be alert enough to consent, and willing to follow the study rules. Pregnant women, prisoners, those needing hospitalization or with severe kidney disease, chronic opioid use before the accident, mental health crises or taking high doses of Vitamin D are excluded.Check my eligibility

What is being tested?

The study tests if a single dose of Vitamin D given in the emergency room can lessen musculoskeletal pain after a car crash and reduce racial disparities in pain outcomes between Black and White individuals. It's a pilot randomized controlled trial where participants will either receive Vitamin D or placebo pills by chance to assess feasibility and potential effectiveness.See study design

What are the potential side effects?

While side effects from one-time high-dose Vitamin D are generally rare and mild, they may include symptoms like nausea, vomiting, weakness or serious ones such as high blood calcium levels which could lead to confusion or heart rhythm problems.

VENTURE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months of enrollment the first participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months of enrollment the first participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months of enrollment the first participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Chronic Pain severity

Enrollment of the 90-participant sample size within 15 months enrollment period (Feasibility)

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

+1 more

VENTURE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Ergocalciferol (Vitamin D2)Active Control1 Intervention

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.

Group II: Ergocalciferol placeboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,591 Total Patients Enrolled

3 Trials studying Musculoskeletal Pain

605 Patients Enrolled for Musculoskeletal Pain

National Institute on Minority Health and Health Disparities (NIMHD)NIH

381 Previous Clinical Trials

1,215,985 Total Patients Enrolled

Matt MauckPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Ergocalciferol (Vitamin D2) for use?

"Ergocalciferol (Vitamin D2) hasn't been proven effective yet, but there is some evidence that it is safe. Therefore, it received a score of 2."

Answered by AI

Does this research opportunity extend to adults over the age of 55?

"Patients must be aged between 18 and 65 in order to participate in this clinical trial, as per the eligibility requirements."

Answered by AI

Who meets the screening criteria for this trial?

"Eligible patients for this medication must suffer from musculoskeletal pain and fall in the age bracket of 18 to 65 years old. Currently, the clinical trial is looking for 90 volunteers in total."

Answered by AI

Can anyone currently participate in this test?

"Unfortunately, this particular study is no longer taking patients. Originally posted on November 11th 2022, the trial was last updated on the first of November. Although this specific research project has wrapped up, there are 59 other trials that are still looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D to ENhance TraUma REcovery

2022. "Vitamin D to ENhance TraUma REcovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05458024.

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