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COMPLETED
NCT05619289
PHASE2

Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-04-12

Completion Date

2026-01-16

Last Updated

2026-05-05

Healthy Volunteers

No

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

Locations (1)

University Of North Carolina

Chapel Hill, North Carolina, United States