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Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

NCT05619289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-05

No results posted yet for this study

Summary

The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question\[s\] it aims to answer are:

* Is the clinical trial protocol feasible?
* Is Vitamin D administration following burn injury safe?
* How does vitamin D cause changes in the immune system in the aftermath of burn injury?

Following informed consent, participants will be asked to:

* Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo)
* Provide a blood sample at baseline and 6 weeks following injury
* Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months.

Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.

Conditions

Interventions

DRUG

Ergocalciferol

One-time, oral dose of 300,000 IU of Ergocalciferol administered via 6 capsules.

DRUG

Placebo

One-time, oral dose of 6 inert capsules matched to the active comparator

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Matthew Mauck, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2026-01-16
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619289 on ClinicalTrials.gov