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Not Yet Recruiting
NCT05619289
Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn
Conditions: Burn Injury, Chronic Pain
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE2
Enrollment: 40
Sponsor: University of North Carolina, Chapel Hill
Location: United States
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 injuryFill 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 ≤ 65 years of ageAdmitted to burn center within 96 hours of thermal burn injurySurgical team has plans for surgical management of the burn wound (e.g.
xenograft and/or autograft, note: in some burn patients the plan will change, but if there is documentation in the note or in communication with the surgical team there are plans for surgical management then the patient will be eligible)Patients experience a thermal burn injury, not an electrical or chemical burn.Has a smart phone with continuous service >1 yearAlert and orientedWilling to take study medication (6 capsules of Vitamin D or placebo)Point of care Vitamin D level <100 ng/mlAble to speak and read EnglishBurn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by the patient on screening)Total Body Surface area burned <30%.Exclusion CriteriaSubstantial comorbid injury (e.g.
long bone fracture)Pregnancy/BreastfeedingPrisoner statusActive psychosis, suicidal ideation, or homicidal ideationRequires an 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, calcipotriolKnown hypercalcemia (based on routine admission laboratory assessment).SarcoidosisHyperphosphatemia (based on routine admission laboratory assessment)Taking Vitamin D supplements in excess of 800 IU daily.
Substantial comorbid injury (e.g., long bone fracture)
Source: ClinicalTrials.gov (NCT05619289). StuddyBuddy aggregates publicly available trial information.