RECRUITING

Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-04-12
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05619289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Matthew Mauck
CONTACT
919-966-5136
matt_mauck@med.unc.edu

Principal Investigator

Matthew Mauck, MD, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University Of North Carolina
Chapel Hill, North Carolina, 27517
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Burn Injury
  • Chronic Pain