Vitamin D and n-3 PUFAs to Prevent Chronic Pain Following Major Thermal Burn Injury



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:9/2/2018
Start Date:July 19, 2018
End Date:October 2020
Contact:Matthew C Mauck, MD, PhD
Email:matt_mauck@med.unc.edu
Phone:888-894-9890

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Pilot, Double-blind, Randomized Controlled, Multi-center Study of the Effects of Fish Oil and Vitamin D in the Prevention of Chronic Pain Following Major Thermal Burn Injury

Interventional trial employing a 2x2 factorial design to test the efficacy of Vitamin D and
n-3 fatty acids [Polyunsaturated fatty acids (PUFAs)] to prevent chronic pain following major
thermal burn injury.


Inclusion Criteria:

1. ≥ 18 years and < 60 years of age

2. Admitted to burn center within 72 hours of thermal burn injury

3. Estimated TBSA ≤ 30%

4. Surgical team have plans to perform a tissue autograft as part of burn management

5. Patients experience a thermal burn injury, not an electrical or chemical burn.

6. Has a telephone to receive follow-up calls.

7. Able to speak and read English

8. Resides within 100 miles of UNC

9. Alert and oriented

10. Willing to take study medication for 6 weeks following enrollment

11. Subjects are capable of giving informed consent.

12. Predicted probability of chronic pain >0.5 when demographic parameters are entered
into a logistic regression model developed from a previous cohort.

Exclusion Criteria:

1. Unwilling to take study drug

2. Allergy to fish oil or corn oil.

3. Patient taking clopidogrel (Plavix)

4. Patient taking warfarin or dabigatran.

5. Substantial comorbid injury (e.g. long bone fracture)

6. Pregnancy/Breastfeeding

7. Prisoner status

8. Chronic daily opioid use prior to burn (>20 mg oral daily morphine equivalents).

9. Active psychosis, suicidal ideation, or homicidal ideation

10. Requires an escharotomy or fasciotomy for the treatment of burn injury.

11. Has a disorder of pain processing or diminished capacity to perceive pain (congenital
insensitivity to pain)

12. Known Child-Pugh liver disease severity classification B or C.

13. Known Chronic kidney disease stage 4 or higher (GFR≤29).

14. Known Hemophilia A/B

15. Known bleeding dyscrasia

16. History of an inability to tolerate fish oil or corn oil.

17. Severe gastroesophageal reflux disease

18. 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).

19. Intubated and sedated at time of enrollment.

20. Hypersensitivity to Vitamin D3, ergocalciferol, calcitriol, alfacalcidol, calcipotriol

21. Hypercalcemia (if not already completed, this will be assessed by clinical labs with
albumin correction prior to enrollment).

22. Hypervitaminosis

23. Sarcoidosis

24. Hyperphosphatemia

25. Arteriosclerosis

26. Active myocardial ischemia

27. Frequent antacid use (calcium carbonate, cimetidine)

28. Cholestyramine or Colestipol use

29. Taking Vitamin D supplements in excess of 800 IU daily.

30. Taking >1g of fish oil per day.
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Matthew C Mauck, MD PhD
Phone: 888-894-9890
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