Clinical trial NCT05619289: Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn
Official title: Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Burn Injury
Chronic Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Follow-up rate 6 weeks following burn injury
timeFrame: 6 weeks
Secondary outcomes:
measure: 25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment
timeFrame: Baseline, 6 weeks
measure: Safety of Vitamin D2 administration in aftermath of burn injury
timeFrame: 6 weeks
measure: By Group Efficacy Estimates Over Year Following Thermal Burn Injury
timeFrame: Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
measure: Opioid cessation
timeFrame: 6 months
measure: Neuropathic pain quality
timeFrame: 6 months
measure: Pain Interference
timeFrame: 6 months
measure: Widespread pain severity
timeFrame: 6 months
measure: Nociceptive quality
timeFrame: 6 months
Other outcomes:
measure: Inflammatory immune cells populations assessed with mass cytometry
timeFrame: 6 weeks
Locations:
city: Chapel Hill
country: United States
facility: University Of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew Mauck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: