Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn

22-1310

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.

2023-04-12

2025-01-01

2025-07-01

Recruiting

Early phase I

40

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 1. Willing to take study medication (6 capsules of Vitamin D or placebo) 2. Point of care Vitamin D level \<100 ng/ml 3. Able to speak and read English 4. Burn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by patient on screening) 5. Total Body surface area burned \<30% Exclusion Criteria 1. Substantial comorbid injury (e.g. long bone fracture) 2. Pregnancy/Breastfeeding 3. Prisoner status 4. Active psychosis, suicidal ideation, or homicidal ideation 5. Requires an emergency/bedside escharotomy or fasciotomy for the treatment of burn injury. 6. Known Child-Pugh liver disease severity classification B or C. 7. Known chronic kidney disease stage 4 or higher (GFR≤29). 8. 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). 9. Intubated and sedated at time of enrollment. 10. Hypersensitivity to Vitamin D3, ergocalciferol, calcitriol, alfacalcidol, calcipotriol 11. Known hypercalcemia (based on routine admission laboratory assessment). 12. Sarcoidosis 13. Hyperphosphatemia (based on routine admission laboratory assessment) 14. Taking Vitamin D supplements in excess of 800 IU daily.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-06-11