Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Last updated: February 16, 2026
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Completed

Phase

2

Condition

Chronic Pain

Hyponatremia

Pain

Treatment

Placebo

Ergocalciferol

Clinical Study ID

NCT05619289
22-1310
K23AT011389-01A1
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 12, 2023
Estimated Completion Date:
January 16, 2026

Connect with a study center

  • University Of North Carolina

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University Of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27517
    United States

    Site Not Available

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