Status:
TERMINATED
Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Chronic Pain Following Thermal Burn Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this study is to develop a safe, effective, and readily available treatment that will prevent chronic pain following Major Thermal Burn Injury (MThBI). Burn survivors are prone to develop ...
Detailed Description
Patients will be screened daily. Patients who meet eligibility criteria will be approached for participation. Patients interested in participating will proceed through informed consent. Once informed ...
Eligibility Criteria
Inclusion
- ≥ 18 years and ≤ 65 years of age
- Admitted to burn center within 72 hours of thermal burn injury
- Estimated Total Body Surface area (TBSA) ≤ 30%
- Surgical team has plans for surgical management of the burn wound (e.g. xenograft and/or autograft).
- Patients experience a thermal burn injury, not an electrical or chemical burn.
- Has a telephone to receive follow-up calls.
- Able to speak and read English
- Resides within 150 miles of study site
- Alert and oriented
- Willing to take study medication for 6 weeks following enrollment
- Subjects are capable of giving informed consent.
- Predicted probability of chronic pain ≥ 0.3 when demographic parameters are entered into a logistic regression model developed from a previous cohort. (Initial pain score entered into this model will be based on the highest pain severity over the initial 24 hours of hospital admission).
- European American or African American
Exclusion
- Unwilling to take study drug
- Allergy to fish oil or corn/soybean oil.
- Patient taking clopidogrel (Plavix)
- Patient taking warfarin or dabigatran.
- Substantial comorbid injury (e.g. long bone fracture)
- Pregnancy/Breastfeeding
- Prisoner status
- Chronic daily opioid use prior to burn (\>20 mg oral daily morphine equivalents).
- Active psychosis, suicidal ideation, or homicidal ideation
- Requires an escharotomy or fasciotomy for the treatment of burn injury.
- Has a disorder of pain processing or diminished capacity to perceive pain (congenital insensitivity to pain)
- Known Child-Pugh liver disease severity classification B or C.
- Known chronic kidney disease stage 4 or higher (GFR≤29).
- Known Hemophilia A/B
- Known bleeding dyscrasia
- History of an inability to tolerate fish oil or corn/soybean oil.
- Severe gastroesophageal reflux disease
- 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
- Hypercalcemia (if not already completed, this will be assessed by clinical labs with albumin correction prior to enrollment).
- Hypervitaminosis
- Sarcoidosis
- Hyperphosphatemia
- Arteriosclerosis
- Active myocardial ischemia
- Frequent antacid use (calcium carbonate, cimetidine)
- Cholestyramine or Colestipol use
- Taking Vitamin D supplements in excess of 800 IU daily.
- Taking \>1g of fish oil per day.
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03313076
Start Date
July 19 2018
End Date
July 31 2020
Last Update
March 17 2025
Active Locations (1)
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1
University Of North Carolina
Chapel Hill, North Carolina, United States, 27517