drugset / Trial / NCT05619289

Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

NCT05619289

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2023-04-12
Primary completion
2026-01-16
Completion
2026-01-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ergocalciferol Small molecule 300000 iu Oral

Indications