Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)