Fish oil and vitamin d tested to stop burn pain before it starts
NCT ID NCT03313076
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving fish oil and vitamin D soon after a burn injury could prevent chronic pain. It included 24 adults with burns covering less than 30% of their body. The trial was stopped early, so results are limited, but the goal was to find a safe, low-cost way to stop pain from becoming long-lasting.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Jul 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University Of North Carolina
Chapel Hill, North Carolina, 27517, United States
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Other studies related to the condition(s) this trial covers.