Overview
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
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.