Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Follow-up rate 6 weeks following burn injury
研究概览
简要总结
The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question[s] it aims to answer are:
- Is the clinical trial protocol feasible?
- Is Vitamin D administration following burn injury safe?
- How does vitamin D cause changes in the immune system in the aftermath of burn injury?
Following informed consent, participants will be asked to:
- Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo)
- Provide a blood sample at baseline and 6 weeks following injury
- Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months.
Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years and ≤ 70 years of age
- •MThBI severe enough to warrant admission to Burn Surgery Service (NOTE: surgery may or may not be indicated)
- •Admission and subsequent enrollment occurs within 1 week of MThBI
- •Patients experience a thermal burn injury, not an electrical or chemical burn.
- •Has a smartphone with continuous service >1 year
- •Alert and oriented
- •Willing to take study medication (6 capsules of Vitamin D or placebo)
- •Point of care Vitamin D level <100 ng/mL
- •Able to speak and read English
- •Burn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by patient on screening)
- •Total Body surface area burned <30%
排除标准
- •Substantial comorbid injury (e.g. long bone fracture)
- •Pregnancy/Breastfeeding
- •Prisoner status
- •Active psychosis, suicidal ideation, or homicidal ideation
- •Requires an emergency/bedside escharotomy or fasciotomy for the treatment of burn injury.
- •Known Child-Pugh liver disease severity classification B or C.
- •Known chronic kidney disease stage 4 or higher (GFR≤29).
- •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
- •Known hypercalcemia (based on routine admission laboratory assessment).
- •Sarcoidosis
- •Hyperphosphatemia (based on routine admission laboratory assessment)
- •Taking Vitamin D supplements in excess of 800 IU daily.
研究组 & 干预措施
Placebo
One time, oral dose of 6 placebo capsules filled with inert powder and encapsulated and masked to be indistinguishable from active comparator.
干预措施: Placebo (Drug)
Vitamin D2 (Ergocalciferol)
One time, oral dose of Vitamin D2 administered via 6 50,000 IU Ergocalciferol capsules. Capsules will be encapsulated and masked to be indistinguishable from placebo.
干预措施: Ergocalciferol (Drug)
结局指标
主要结局
Follow-up rate 6 weeks following burn injury
时间窗: 6 weeks
The proportion of patients who are able to follow-up at 6 weeks and complete a questionnaire will be calculated. To meet the primary outcome, follow-up will be \>80% at 6 weeks.
次要结局
- 25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment(Baseline, 6 weeks)
- By Group Efficacy Estimates Over Year Following Thermal Burn Injury(Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months)
- Opioid cessation(6 months)
- Pain Interference(6 months)
- Widespread pain severity(6 months)
- Safety of Vitamin D2 administration in aftermath of burn injury(6 weeks)
- Neuropathic pain quality(6 months)
- Nociceptive quality(6 months)