Vitamin D and n-3 PUFAs to Prevent Chronic Pain Following Major Thermal Burn Injury
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ClinicalTrials.gov Identifier: NCT03313076 |
Recruitment Status :
Terminated
(COVID-19 global pandemic, and study funding period ended 7/31/2020.)
First Posted : October 18, 2017
Last Update Posted : August 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Chronic Pain Following Thermal Burn Injury | Drug: Omega-3 fatty acids (fish oil) Drug: Vitamin D3 (cholecalciferol) Drug: Vitamin D3 (cholecalciferol) placebo Drug: Omega-3 fatty acid placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | 2x2 Factorial design |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double-blind |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 19, 2018 |
Actual Primary Completion Date : | July 31, 2020 |
Actual Study Completion Date : | July 31, 2020 |

Arm | Intervention/treatment |
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Experimental: n-3 PUFA (O3FA) + Vitamin D3
4g fish oil in 4 softgels (n-3 PUFA/O3FA) + 2000 IU Vitamin D3 in 1 capsule
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Drug: Omega-3 fatty acids (fish oil)
4 capsules comprising approximately 2 grams of 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:
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:
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Experimental: n-3 PUFA (O3FA) Placebo + Vitamin D3
4g of corn/soy oil blend in 4 softgels + 2000 IU Vitamin D3 in 1 capsule
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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:
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:
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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
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Drug: Omega-3 fatty acids (fish oil)
4 capsules comprising approximately 2 grams of 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:
Drug: Vitamin D3 (cholecalciferol) placebo 1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
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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
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Drug: Vitamin D3 (cholecalciferol) placebo
1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
Other Names:
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:
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- 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.
- Percent of participants who are compliant with follow-up (Feasibility). [ Time Frame: Week 6 ]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 over the year following major burn injury. >80% of enrolled participants at 6 weeks following 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.
- 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).
- General mental health by treatment group measured by the SF-12 general mental health component scores [ Time Frame: 6 weeks following burn injury ]Assessment of mental health will be determined by the SF-12 mental component score. The 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.
- 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.
- 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 severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores reflect greater pain interference.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 18 years and ≤ 65 years of age
- Admitted to burn center within 72 hours of thermal burn injury
- Estimated 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 UNC
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313076
United States, North Carolina | |
University Of North Carolina | |
Chapel Hill, North Carolina, United States, 27517 |
Principal Investigator: | Matthew C Mauck, MD, PhD | University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT03313076 |
Other Study ID Numbers: |
17-1971 |
First Posted: | October 18, 2017 Key Record Dates |
Last Update Posted: | August 4, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
burn injury thermal burn injury omega 3 fatty acids vitamin D |
fish oil chronic pain chronic pain due to trauma |
Chronic Pain Wounds and Injuries Burns Pain Neurologic Manifestations Vitamin D Ergocalciferols Cholecalciferol |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |