Chronic Pain Following Thermal Burn InjuryPhase 2NCT03313076
Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
A Phase 2 study testing Omega-3 fatty acids (fish oil) and Vitamin D3 (cholecalciferol) in people with Chronic Pain Following Thermal Burn Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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 chronic pain and there is an urgent unmet need for preventative treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain Following Thermal Burn Injury
- What is being tested?
- Omega-3 fatty acids (fish oil) and Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 31 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of North Carolina
Chapel Hill, North Carolina, 27517
About this study
Official title: 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.
Read the 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.
- Being tested
- Omega-3 fatty acids (fish oil), Vitamin D3 (cholecalciferol), Vitamin D3 (cholecalciferol) placebo, Omega-3 fatty acid placebo
- Keywords
- burn injury, thermal burn injury, omega 3 fatty acids, vitamin D, fish oil, chronic pain, chronic pain due to trauma
- Medical subject headings
- Burns, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acids (fish oil)Drug
Also called Fish oil, n-3 fatty acids
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
Vitamin D3 (cholecalciferol)Drug
Also called Cholecalciferol, Vitamin D3
1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Vitamin D3 (cholecalciferol) placeboDrug
Also called Placebo, inert white powder, Vitamin D3 Matching Placebo
1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Omega-3 fatty acid placeboDrug
Also called Placebo, corn/soy oil soft gels, PUFA Matching Placebo
4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA (O3FA) + Vitamin D3 | Experimental | 4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule Receives: Drug: Omega-3 fatty acids (fish oil); Drug: Vitamin D3 (cholecalciferol) |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 | Experimental | 4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule Receives: Drug: Vitamin D3 (cholecalciferol); Drug: Omega-3 fatty acid placebo |
| n-3 PUFAs (O3FA) + Vitamin D3 Placebo | Experimental | 4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule Receives: Drug: Omega-3 fatty acids (fish oil); Drug: Vitamin D3 (cholecalciferol) placebo |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Placebo comparator | 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 Receives: Drug: Vitamin D3 (cholecalciferol) placebo; Drug: Omega-3 fatty acid placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Review of Treatment-Related Adverse Events
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).
Measured: 6 weeks following burn injury
Percent of Participants Who Are Compliant With Follow-up (Feasibility)
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).
Measured: 6 weeks following burn injury
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
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.
Measured: Over 1 year following MThBI
Secondary outcomes (4)
Sex Differences in Treatment Response Based on Pain Scores
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).
Measured: 6 weeks following burn injury
General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores
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.
Measured: 6 weeks following burn injury
General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores
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.
Measured: 6 weeks following burn injury
Pain Interference by Treatment Group Measured by the Brief Pain Inventory
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.
Measured: 6 weeks following burn injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start19 Jul 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: COVID-19 global pandemic, and study funding period ended 7/31/2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Pain Following Thermal Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Factorial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew C Mauck, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313076
- Sponsor's protocol ID
- 17-1971
- Status last verified
- Mar 2021
- First submitted
- 20 Sep 2017
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03313076
- Acronym / sponsor ID
- 17-1971
- Keywords
- burn injury, thermal burn injury, omega 3 fatty acids, vitamin D, fish oil, chronic pain, chronic pain due to trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 global pandemic, and study funding period ended 7/31/2020.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Posted 26 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 Factorial design
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA (O3FA) + Vitamin D3 | Experimental | Drug: Omega-3 fatty acids (fish oil), Drug: Vitamin D3 (cholecalciferol)4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 | Experimental | Drug: Vitamin D3 (cholecalciferol), Drug: Omega-3 fatty acid placebo4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule |
| n-3 PUFAs (O3FA) + Vitamin D3 Placebo | Experimental | Drug: Omega-3 fatty acids (fish oil), Drug: Vitamin D3 (cholecalciferol) placebo4g fish oil in 4 softgels (n-3 PUFA/O3FA) + Vitamin D3 matching Placebo, an inert white powder placebo in 1 capsule |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Placebo comparator | Drug: Vitamin D3 (cholecalciferol) placebo, Drug: Omega-3 fatty acid placebo4g n-3 PUFA/O3FA Matching Placebo, a corn/soy oil blend in 4 softgels + inert white powder Vitamin D3 matching placebo in 1 capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥ 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.
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acids (fish oil)Also: Fish oil, n-3 fatty acids4 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 | Drug | n-3 PUFA (O3FA) + Vitamin D3, n-3 PUFAs (O3FA) + Vitamin D3 Placebo |
| Vitamin D3 (cholecalciferol)Also: Cholecalciferol, Vitamin D31 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment. | Drug | n-3 PUFA (O3FA) + Vitamin D3, n-3 PUFA (O3FA) Placebo + Vitamin D3 |
| Vitamin D3 (cholecalciferol) placeboAlso: Placebo, inert white powder, Vitamin D3 Matching Placebo1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment. | Drug | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo, n-3 PUFAs (O3FA) + Vitamin D3 Placebo |
| Omega-3 fatty acid placeboAlso: Placebo, corn/soy oil soft gels, PUFA Matching Placebo4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment. | Drug | n-3 PUFA (O3FA) Placebo + Vitamin D3, n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo |
Primary outcome
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).
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).
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.
4 secondary outcomes
Sex Differences in Treatment Response Based on Pain Scores
Time frame: 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
General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores
Time frame: 6 weeks following burn injury
Pain Interference by Treatment Group Measured by the Brief Pain Inventory
Time frame: 6 weeks following burn injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew C Mauck, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 fatty acids (fish oil) and Vitamin D3 (cholecalciferol) in people with Chronic Pain Following Thermal Burn Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Review of Treatment-Related Adverse Events (time frame: 6 weeks following burn injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.