Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

University of North Carolina (UNC)

Status and phase: Enrolling; Phase 2

Conditions: Chronic Pain; Burn Injury

Treatments: Drug: Placebo; Drug: Ergocalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05619289

22-1310

K23AT011389-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• ≥ 18 years and ≤ 70 years of age
• MThBI severe enough to warrant admission to Burn Surgery Service (NOTE: surgery may or may not be indicated)
• Admission and subsequent enrollment occurs within 1 week of MThBI
• Patients experience a thermal burn injury, not an electrical or chemical burn.
• Has a smartphone 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 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 emergency/bedside 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Vitamin D2 (Ergocalciferol)

Active Comparator group

Description:

One time, oral dose of Vitamin D2 administered via 6 50,000 IU Ergocalciferol capsules. Capsules will be encapsulated and masked to be indistinguishable from placebo.

Treatment:

Drug: Ergocalciferol

Placebo

Placebo Comparator group

Description:

One time, oral dose of 6 placebo capsules filled with inert powder and encapsulated and masked to be indistinguishable from active comparator.

Treatment:

Drug: Placebo