Using Vitamin D to Reduce Chronic Pain After Burn Injury

Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn

This study is testing if giving vitamin D to people right after a burn injury can help prevent long-lasting pain and improve their immune response.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of North Carolina, Chapel Hill (other)
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT05619289 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to investigate whether vitamin D can prevent chronic pain following burn injuries and to explore the biological mechanisms involved. Participants will receive either vitamin D or a placebo shortly after their burn injury and will be monitored for pain levels and immune system changes through blood samples and surveys. The study will assess the feasibility and safety of vitamin D administration in this context, as well as its effects on chronic pain and immune responses over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have sustained a thermal burn injury and experience significant acute pain.

Not a fit: Patients with substantial comorbid injuries or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach to managing chronic pain in burn survivors.

How similar studies have performed: While the specific use of vitamin D for chronic pain after burn injuries is novel, other studies have explored vitamin D's role in pain management with varying degrees of success.

Eligibility 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.

Where this trial is running

Chapel Hill, North Carolina

• University Of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Matthew Mauck, MD, PhD — University of North Carolina, Chapel Hill
• Study coordinator: Matthew Mauck

Conditions: Burn Injury, Chronic Pain