A Phase 2 interventional study of Omega-3 fatty acids (fish oil) and Vitamin D3 (cholecalciferol) in Chronic Pain Following Thermal Burn Injury, sponsored by University of North Carolina, Chapel Hill. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
Among 336 studies in Burns with a site in United States — 40 open to participants now, 52 under way, 5 of them phase 3. Burns · United States.
Among the 336 studies in Burns with a site in United States, this one is the 141st largest by enrollment of the 272 interventional ones that give a count, is one of 12 that started in 2018, is one of 32 in phase 2, and was the 208th registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →40 of the 336 studies in Burns with a site in United States are open now. Recruiting first, the newest first:
Jason Sperry · Sites in United States
Ages 18–75
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–65 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
University of Tennessee · Sites in United States
Ages 18–80
The Metis Foundation · Sites in United States
Ages 18–85
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
336 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 35 · Phase 2 56 · Phase 3 30 · Phase 4 25
First in 1992; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 40 across 663 interventional studies indexed under Burns.
Median enrollment 26 across the 272 interventional studies, 59 across the 61 observational. Of the 225 that completed or were terminated, 74 (33%) have results posted.
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82 of 336 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 7 studies filed under Burns — fewer than ten, so there is no comparison to draw.
10 of the studies in Burns with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05223998The Metis FoundationManual Implantation of Full-Thickness Skin Microcolumns | 2026-12 |
| NCT07317271Johns Hopkins UniversityVR-PMR for Post-Burn Symptoms | 2026-12 |
| NCT05462860The Metis FoundationSuprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds | 2026-12-09 |
| NCT01297400Skingenix, Inc.Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns | 2026-12-31 |
| NCT07221903University of WashingtonThe Lateral, Anterior, Medial (LAM) Femoral Cutaneous Block: A Case Series Harborview Medical Center, Seattle, WA | 2026-12-31 |
Add all 10 to your calendar (.ics) → With an account.
Among the 336 studies in Burns with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
Drug: Omega-3 fatty acids (fish oil) · Drug: Vitamin D3 (cholecalciferol)
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
Drug: Vitamin D3 (cholecalciferol) · Drug: Omega-3 fatty acid 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) · Drug: Vitamin D3 (cholecalciferol) 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: Vitamin D3 (cholecalciferol) placebo · Drug: Omega-3 fatty acid placebo
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
Also known as: Fish oil, n-3 fatty acids
1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
Also known as: Cholecalciferol, Vitamin D3
1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Also known as: Placebo, inert white powder, Vitamin D3 Matching Placebo
4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
Also known as: Placebo, corn/soy oil soft gels, PUFA Matching Placebo
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).
Time frame: 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).
Time frame: 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.
Time frame: Over 1 year following MThBI
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks following burn injury
| Milestone | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo |
|---|---|---|---|---|
| Started | 7 | 6 | 6 | 5 |
| Completed | 5 | 4 | 4 | 3 |
| Not completed | 2 | 2 | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 2 | 2 |
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).
| adverse events | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo |
|---|---|---|---|---|
| Unrelated | 3 | 4 | 2 | 2 |
| Unlikely Related | 1 | 3 | 2 | 3 |
| Possibly Related | 1 | 2 | 0 | 0 |
| Probably Related | 0 | 0 | 0 | 0 |
| Definitely Related | 1 | 1 | 0 | 0 |
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).
| percentage of participants | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo |
|---|---|---|---|---|
| Percent of Participants Who Are Compliant With Follow-up (Feasibility) | 100 | 60 | 83.3 | 80 |
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.
| score on a scale | Omega-3 | No Omega 3 Treatment | Vitamin D | No Vitamin D Treatment |
|---|---|---|---|---|
| Baseline (Day 1) | 7.19 ± 1.15 | 7.57 ± 1.83 | 7.01 ± 1.72 | 7.65 ± 1.14 |
| Week 1 | 5.7 ± 2.21 | 5.50 ± 2.21 | 5 ± 2.65 | 6.09 ± 2.21 |
| Week 2 | 4.5 ± 2.99 | 3.8 ± 3.01 | 3.22 ± 2.33 | 4.91 ± 3.27 |
| Week 3 | 2.0 ± 2.45 | 2.8 ± 2.49 | 1.9 ± 1.97 | 2.90 ± 2.85 |
| Week 4 | 1.73 ± 2.20 | 2.33 ± 1.94 | 1.6 ± 1.78 | 2.4 ± 2.32 |
| Week 5 | 1.22 ± 1.48 | 1.43 ± 1.27 | 1 ± 1.15 | 1.56 ± 1.51 |
| Week 6 | 1.6 ± 1.58 | 1.57 ± 2.94 | 0.75 ± 1.04 | 2.33 ± 2.65 |
| Month 3 | 0.67 ± 1.15 | 0.33 ± 0.58 | 0.25 ± 0.5 | 1.0 ± 1.41 |
| Month 6 | 1.14 ± 1.46 | 0.33 ± 0.82 | 0.67 ± 1.03 | 0.86 ± 1.46 |
| Month 12 | 1.2 ± 2.17 | 0.5 ± 1.0 | 0.6 ± 0.89 | 1.25 ± 2.5 |
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).
| units on a scale | Omega-3 | No Omega 3 Treatment | Vitamin D | No Vitamin D Treatment |
|---|---|---|---|---|
| Male | 1.43 ± 1.81 | 1.80 ± 3.49 | 0.33 ± 0.81 | 2.83 ± 3.01 |
| Female | 2.00 ± 1.00 | 1.00 ± 1.42 | 2 ± 0 | 1.33 ± 1.52 |
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.
| score on a scale | Omega-3 | No Omega 3 Treatment | Vitamin D | No Vitamin D Treatment |
|---|---|---|---|---|
| General Mental Health as Measured by the Short Form (SF)-12 General Mental Health Component Scores | 49.98 ± 9.98 | 48.29 ± 10.79 | 52.80 ± 6.37 | 46.16 ± 11.92 |
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.
| score on a scale | Omega-3 | No Omega 3 Treatment | Vitamin D | No Vitamin D Treatment |
|---|---|---|---|---|
| General Physical Health by Treatment Group Measured by the SF-12 General Physical Health Component Scores | 40.84 ± 6.25 | 40.12 ± 6.40 | 40.83 ± 3.85 | 40.29 ± 7.86 |
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.
| score on a scale | Omega-3 | No Omega 3 Treatment | Vitamin D | No Vitamin D Treatment |
|---|---|---|---|---|
| Pain Interference by Treatment Group Measured by the Brief Pain Inventory | 11.60 ± 12.76 | 13.71 ± 20.30 | 5.5 ± 6.85 | 18.67 ± 19.03 |
Collected over After randomization through 6 weeks of active treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| n-3 PUFA (O3FA) + Vitamin D3 | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| n-3 PUFAs (O3FA) + Vitamin D3 Placebo | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Event | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo |
|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 1/7 | 0/6 | 1/6 | 1/5 |
| Dry SkinSkin and subcutaneous tissue disorders | 0/7 | 0/6 | 0/6 | 1/5 |
| Gastrointestinal painGastrointestinal disorders | 0/7 | 0/6 | 0/6 | 1/5 |
| HyperglycemiaMetabolism and nutrition disorders | 0/7 | 0/6 | 0/6 | 1/5 |
| AnemiaBlood and lymphatic system disorders | 0/7 | 0/6 | 1/6 | 0/5 |
| DysgeusiaGastrointestinal disorders | 1/7 | 0/6 | 1/6 | 0/5 |
| Medication administration errorInvestigations | 1/7 | 0/6 | 1/6 | 0/5 |
| DiarrheaGastrointestinal disorders | 0/7 | 0/6 | 1/6 | 0/5 |
| Mood SwingsPsychiatric disorders | 0/7 | 0/6 | 1/6 | 0/5 |
| TachycardiaCardiac disorders | 0/7 | 0/6 | 1/6 | 0/5 |
| Age, Continuous(years) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Mean | 38.8 ± 13.7 | 34.7 ± 12.6 | 26.9 ± 6.9 | 30.7 ± 9.39 | 32.6 ± 11.5 |
| Sex: Female, Male(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Female | 1 | 1 | 2 | 1 | 5 |
| Male | 6 | 5 | 4 | 4 | 19 |
| Race/Ethnicity, Customized(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Black American | 3 | 4 | 3 | 3 | 13 |
| White American | 4 | 2 | 3 | 2 | 11 |
| Region of Enrollment(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| United States | 7 | 6 | 6 | 5 | 24 |
| Education(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Completed High School | 1 | 1 | 4 | 2 | 8 |
| Post-high school education | 3 | 4 | 1 | 2 | 10 |
| College Graduate or beyond | 3 | 1 | 1 | 1 | 6 |
| Income(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| <$40,000/year | 1 | 1 | 3 | 2 | 7 |
| $40,000-$59,999/year | 1 | 2 | 0 | 1 | 4 |
| $60,000-$99,999/year | 0 | 1 | 0 | 1 | 2 |
| >$100,000/year | 2 | 0 | 0 | 0 | 2 |
| Refused/Don't know | 3 | 2 | 3 | 1 | 9 |
| Total Body Surface Area Burned(Percent total body surface area burned) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Mean | 4.8 ± 4.01 | 7.9 ± 6.4 | 6.0 ± 4.7 | 5.3 ± 3.9 | 6.1 ± 4.7 |
| Type of Thermal Burn(Participants) | n-3 PUFA (O3FA) + Vitamin D3 | n-3 PUFA (O3FA) Placebo + Vitamin D3 | n-3 PUFAs (O3FA) + Vitamin D3 Placebo | n-3 PUFA (O3FA) Placebo + Vitamin D3 Placebo | Total |
|---|---|---|---|---|---|
| Flame | 4 | 3 | 2 | 3 | 12 |
| Contact | 0 | 0 | 1 | 0 | 1 |
| Scald | 0 | 2 | 2 | 2 | 6 |
| Other | 2 | 1 | 1 | 0 | 4 |
| Not reported | 1 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Time frame: 12-36 months following publication
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.
Ran from Jul 2018 to primary completion in Jul 2020, 24 months.
Results were first posted in Jul 2021, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Omega-3 fatty acid · Cholecalciferol
University of North Carolina, Chapel Hill →