Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major The… (NCT03313076) | Clinical Trial Compass
TerminatedPhase 2
Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
Stopped: COVID-19 global pandemic, and study funding period ended 7/31/2020.
United States24 participantsStarted 2018-07-19
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Qualitative Review of Treatment-Related Adverse Events
Timeframe: 6 weeks following burn injury
2
Percent of Participants Who Are Compliant With Follow-up (Feasibility)
Timeframe: 6 weeks following burn injury
3
By Group Efficacy Estimates Over Year Following Thermal Burn Injury