Phase
Condition
Chronic Pain
Hyponatremia
Pain
Treatment
Placebo
Ergocalciferol
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Connect with a study center
University Of North Carolina
Chapel Hill, North Carolina 27517
United StatesSite Not Available
University Of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27517
United StatesSite Not Available

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