Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury

April 17, 2026 updated by: University of North Carolina, Chapel Hill

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

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 chronic pain and there is an urgent unmet need for preventative treatments. The preventative treatments proposed for this study, Omega-3 Fatty Acids (O3FA) and Vitamin D have been selected given effectiveness across a range of painful musculoskeletal disorders and their wide availability and low cost. This study is a 2x2 factorial, double-blind, placebo-controlled randomized controlled trial test for the effectiveness of O3FA and Vitamin D to prevent chronic pain development. Burn survivors will be enrolled who have experienced thermal burns that cover less than 30% total body surface area that are severe enough to warrant surgical management, which represents the most common burn injury characteristics. Patients will be enrolled within 72 hours of their burn, and randomized via 1:1:1:1 allocation to receive placebo, O3FA, Vitamin D or both. The investigators will obtain blood samples on enrollment and at 6 weeks to assist in elucidating key mechanisms by which O3FA and Vitamin D reduce chronic pain following MThBI. Chronic pain severity, assessed with a 0-10 numeric rating scale at 6 weeks, 3 months, 6 months and 1 year will be entered into a repeated-measures model. Model estimated contrasts will serve as the primary outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 consent is obtained, an initial questionnaire will be administered, a blood draw will be performed to assess for baseline Vitamin D/O3FA concentration and immune profile. Then patients will be randomized into one of 4 treatment arms in 1:1:1:1 allocation. Patients will receive study drug for 6 weeks following burn injury. Adverse event monitoring will occur daily while inpatient and weekly once discharged from the hospital through 6 weeks. Patient compliance with the study drug will be assessed via patient-reported reported missing doses, pill counts at the end of the study, and a 6-week blood draw in which Vitamin D/O3FA levels and immune profile will be assessed. Patient-reported outcomes will be collected via follow-up survey at 6 weeks, 3 months, 6 months, and 1 year following burn injury.s, and 1 year following burn injury.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: n-3 PUFA (O3FA) + Vitamin D3
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Drug: Omega-3 fatty acids (fish oil)
4 capsules comprising approximately 2 grams of Eicosapentaenoic acid/Docosahexaenoic acid (EPA/DHA) in a 3:2 ratio (this will require a total dose of 4 grams of fish oil). This will be administered daily, by mouth for 6 weeks
Other Names:
  • n-3 fatty acids
  • Fish oil
Drug: Vitamin D3 (cholecalciferol)
1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Cholecalciferol
  • Vitamin D3
Experimental: n-3 PUFA (O3FA) Placebo + Vitamin D3
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Drug: Vitamin D3 (cholecalciferol)
1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Cholecalciferol
  • Vitamin D3
Drug: Omega-3 fatty acid placebo
4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Placebo, corn/soy oil soft gels
  • PUFA Matching Placebo
Experimental: n-3 PUFAs (O3FA) + Vitamin D3 Placebo
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule
Drug: Omega-3 fatty acids (fish oil)
4 capsules comprising approximately 2 grams of Eicosapentaenoic acid/Docosahexaenoic acid (EPA/DHA) in a 3:2 ratio (this will require a total dose of 4 grams of fish oil). This will be administered daily, by mouth for 6 weeks
Other Names:
  • n-3 fatty acids
  • Fish oil
Drug: Vitamin D3 (cholecalciferol) placebo
1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Placebo, inert white powder
  • Vitamin D3 Matching Placebo
Placebo Comparator: n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo
4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule
Drug: Omega-3 fatty acid placebo
4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Placebo, corn/soy oil soft gels
  • PUFA Matching Placebo
Drug: Vitamin D3 (cholecalciferol) placebo
1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
  • Placebo, inert white powder
  • Vitamin D3 Matching Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qualitative Review of Treatment-Related Adverse Events
Time Frame: 6 weeks following burn injury
A primary objective of this pilot study is to ensure safety of both treatments as well as combined. A qualitative review of treatment-related adverse events will be performed and a determination about the degree of relatedness of each adverse event with the intervention using CTCAE criteria will be made as CTCAE criteria assesses relatedness to therapy. Investigator reviewing the details of each adverse event rated the likelihood of relatedness to the study drug on a scale: (unrelated, unlikely, possible, probably, definitely).
6 weeks following burn injury
Percent of Participants Who Are Compliant With Follow-up (Feasibility)
Time Frame: 6 weeks following burn injury
The primary objective of this pilot study is to ensure that the investigators are able to make follow-up assessments on a majority of participants. The percent of participants who are compliant with follow-up will be determined 6 weeks following major thermal burn injury. Feasibility is defined as >80% of enrolled participants at 6 weeks following Major Thermal Burn Injury (MThBI).
6 weeks following burn injury
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Time Frame: Over 1 year following MThBI
Estimates of efficacy will be obtained via repeated measures analysis of pain severity over the 1 year following injury using mixed effects models. Pain will be assessed using a 0-10 numeric rating scale with 0 indicating no pain and 10 indicating pain as severe as you can imagine. Higher scores represent worse outcome. These values (collected in identical fashion over 1 year following burn injury) will be entered into a linear mixed model, and overall effect estimates (beta coefficients) among groups will be determined. Final model was a piece-wise linear mixed model, with a cut-point at 6 weeks. Mixed models were adjusted for age, sex, race, initial pain severity. Every 1 unit change in beta coefficient represents a 1 unit change in pain severity on the 0-10 numeric rating scale.
Over 1 year following MThBI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex Differences in Treatment Response Based on Pain Scores
Time Frame: 6 weeks following burn injury
Examines existence of gender-based treatment response differences in pain severity measured by a 0-10 numeric rating scale where 0 is no pain and 10 is the most severe pain. Higher scores reflect greater pain (poor outcome).
6 weeks following burn injury
General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores
Time Frame: 6 weeks following burn injury
Assessment of mental health will be determined by the short form (SF)-12 mental component score. The short form SF-12 Health Survey is a 12-item participant completed questionnaire to measure general health. It includes a mental component score (MCS): ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good mental health.
6 weeks following burn injury
General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores
Time Frame: 6 weeks following burn injury
Assessment of physical health will be determined by the SF-12 physical component score. The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health. It includes a physical component score (PCS): ranging from 0 to 100 points. Low values represent a poor physical health and high values represent a good physical health.
6 weeks following burn injury
Pain Interference by Treatment Group Measured by the Brief Pain Inventory
Time Frame: 6 weeks following burn injury
The degree to which pain interferes with important life function will be determined by the Brief Pain Inventory. This is a validated, self-reported scale that measures the severity of pain based on the average pain experienced and assesses impact of pain across 7 domains of life function (e.g., enjoyment of life, relationships, normal work). The total severity scores range from 0 (no interference) to 70 (maximum interference). Higher scores reflect greater pain interference.
6 weeks following burn injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew C Mauck, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-1971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) independently.

IPD Sharing Time Frame

12-36 months following publication

IPD Sharing Access Criteria

Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC independently.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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