Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

NCT ID: NCT05619289

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-02-01

Brief 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.

Conditions

Burn Injury; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D2 (Ergocalciferol)

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.

Group Type: ACTIVE_COMPARATOR

Ergocalciferol

Intervention Type: DRUG

One-time, oral dose of 300,000 IU of Ergocalciferol administered via 6 capsules.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One-time, oral dose of 6 inert capsules matched to the active comparator

Interventions

Ergocalciferol

One-time, oral dose of 300,000 IU of Ergocalciferol administered via 6 capsules.

Intervention Type: DRUG

Placebo

One-time, oral dose of 6 inert capsules matched to the active comparator

Intervention Type: DRUG

Other Intervention Names

Vitamin D2, Calciferol, Drisdol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Mauck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University Of North Carolina

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Mauck

Role: CONTACT

matt_mauck@med.unc.edu

919-966-5136

Facility Contacts

Matthew C Mauck, MD PhD

Role: primary

matt_mauck@med.unc.edu

919-966-5136

Other Identifiers

K23AT011389-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-1310

Identifier Type: -

Identifier Source: org_study_id