Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Ergocalciferols; Vitamin D

Criteria

Inclusion Criteria

• ≥ 18 years and ≤ 65 years of age

• Admitted to burn center within 96 hours of thermal burn injury

• Surgical team has plans for surgical management of the burn wound (e.g. xenograft and/or autograft, note: in some burn patients the plan will change, but if there is documentation in the note or in communication with the surgical team there are plans for surgical management then the patient will be eligible)

• Patients experience a thermal burn injury, not an electrical or chemical burn.

• Has a smart phone with continuous service >1 year

• Alert and oriented

• Willing to take study medication (6 capsules of Vitamin D or placebo)

• Point of care Vitamin D level <100 ng/ml

• Able to speak and read English

• Burn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by the patient on screening)

• Total Body Surface area burned <30%.

Exclusion Criteria

• Substantial comorbid injury (e.g. long bone fracture)

• Pregnancy/Breastfeeding

• Prisoner status

• Active psychosis, suicidal ideation, or homicidal ideation

• Requires an escharotomy or fasciotomy for the treatment of burn injury.

• Known Child-Pugh liver disease severity classification B or C.

• Known chronic kidney disease stage 4 or higher (GFR≤29).

• No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient).

• Intubated and sedated at time of enrollment.

• Hypersensitivity to Vitamin D3, ergocalciferol, calcitriol, alfacalcidol, calcipotriol

• Known hypercalcemia (based on routine admission laboratory assessment).

• Sarcoidosis

• Hyperphosphatemia (based on routine admission laboratory assessment)

• Taking Vitamin D supplements in excess of 800 IU daily. Substantial comorbid injury (e.g., long bone fracture)