Fish oil and vitamin d tested to stop burn pain before it starts

NCT ID NCT03313076

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2020

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic pain following thermal burn injury are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

burn Chronic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University Of North Carolina

    Chapel Hill, North Carolina, 27517, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.