Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

NCT05619289 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 22-1310K23AT011389-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Follow-up rate 6 weeks following burn injury

  The proportion of patients who are able to follow-up at 6 weeks and complete a questionnaire will be calculated. To meet the primary outcome, follow-up will be \>80% at 6 weeks.

  6 weeks

Secondary Outcomes (8)

• 25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment

  Baseline, 6 weeks

• Safety of Vitamin D2 administration in aftermath of burn injury

  6 weeks

• By Group Efficacy Estimates Over Year Following Thermal Burn Injury

  Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months

• Opioid cessation

  6 months

• Neuropathic pain quality

  6 months

Other Outcomes (1)

• Inflammatory immune cells populations assessed with mass cytometry

  6 weeks

Study Arms (2)

Vitamin D2 (Ergocalciferol)

ACTIVE COMPARATOR

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.

Drug: Ergocalciferol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ergocalciferol DRUG

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

Also known as: Vitamin D2, Calciferol, Drisdol

Vitamin D2 (Ergocalciferol)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University Of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Burns; Chronic Pain

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Matthew Mauck, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: April 12, 2023
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 12 and continuing for 36 months after publication
• Access Criteria: Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)