Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Nov 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether taking vitamin D can help prevent chronic pain after a burn injury. Researchers want to understand how vitamin D affects the immune system and whether it is safe to use after a burn. The trial is looking for adult participants aged 18 to 70 who have experienced a serious thermal burn and are admitted to the hospital for treatment. Participants will take either vitamin D or a placebo (a non-active pill) just once after their injury and will provide blood samples and complete surveys about their pain and recovery over the following months.

If you decide to participate, you’ll be asked to take 6 capsules by mouth after your burn, give blood samples at the start and 6 weeks later, and fill out daily and weekly surveys about your pain and healing. The study aims to see if there are differences in pain levels and side effects between those who take vitamin D and those who take the placebo. It’s important to know that this trial is only for people with certain types of burn injuries, and there are specific health conditions that may exclude you from participating. Your involvement can help researchers learn more about how vitamin D might improve recovery from burn injuries.

Gender

ALL

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.