Vitamin D for Chronic Pain After Burns
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Must not be taking: Vitamin D supplements
Disqualifiers: Pregnancy, Psychosis, Liver disease, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking Vitamin D supplements in excess of 800 IU daily, you may not be eligible to participate.
What evidence supports the effectiveness of the drug Vitamin D2 (Ergocalciferol) for chronic pain after burns?
Research suggests that low levels of Vitamin D are linked to worse chronic pain outcomes, and supplementation may improve pain, sleep, and quality of life in chronic pain patients. Vitamin D is thought to help with pain by interacting with pain signaling pathways and immune cells, although more studies are needed to understand these effects fully.
12345Is Vitamin D safe for use in humans, particularly for those with chronic pain after burns?
Vitamin D, including forms like ergocalciferol (Vitamin D2), is generally considered safe for humans. It is important for bone and muscle health, and deficiencies can lead to issues like muscle weakness and itching, which are common in burn patients. However, more research is needed to fully understand its safety and effects in adult burn patients.
26789How does the drug Ergocalciferol differ from other treatments for chronic pain after burns?
Ergocalciferol (Vitamin D2) is unique because it addresses chronic pain potentially linked to vitamin D deficiency, which is not typically targeted by standard pain medications. Unlike traditional analgesics, it may help improve pain by correcting vitamin D levels, especially in individuals with compromised vitamin D status, which is common in burn patients.
1281011Eligibility Criteria
Adults aged 18-70 with thermal burns covering less than 30% of their body, experiencing significant pain (≥7/10), and admitted for surgical burn wound management. Participants must be alert, speak English, willing to take study medication, have a smartphone, and not have severe kidney disease or certain other health conditions.Inclusion Criteria
Able to speak and read English
I am mentally alert and aware of my surroundings.
My burn injury is caused by heat, not electricity or chemicals.
+10 more
Exclusion Criteria
Prisoner status
You have high levels of phosphorus in your blood.
You have high levels of calcium in your blood.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo)
1 day
1 visit (in-person)
Monitoring
Participants provide a blood sample at baseline and 6 weeks following injury and fill out surveys daily while in the hospital, weekly through 6 weeks
6 weeks
Multiple visits (in-person and virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveys at 3 months and 6 months
6 months
2 visits (in-person)
Participant Groups
This trial is testing if Vitamin D can prevent chronic pain after a burn injury by comparing the effects of Vitamin D capsules to placebo. It will also explore how Vitamin D affects immune system changes post-injury through blood samples and surveys up to six months.
2Treatment groups
Active Control
Placebo Group
Group I: Vitamin D2 (Ergocalciferol)Active Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
One time, oral dose of 6 placebo capsules filled with inert powder and encapsulated and masked to be indistinguishable from active comparator.
Ergocalciferol is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Ergocalciferol for:
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
🇪🇺 Approved in European Union as Ergocalciferol for:
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
🇨🇦 Approved in Canada as Ergocalciferol for:
- Rickets
- Osteomalacia
- Hypoparathyroidism
- Vitamin D deficiency
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Of North CarolinaChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Vitamin D and Its Potential Interplay With Pain Signaling Pathways. [2021]About 50 million of the U.S. adult population suffer from chronic pain. It is a complex disease in its own right for which currently available analgesics have been deemed woefully inadequate since ~20% of the sufferers derive no benefit. Vitamin D, known for its role in calcium homeostasis and bone metabolism, is thought to be of clinical benefit in treating chronic pain without the side-effects of currently available analgesics. A strong correlation between hypovitaminosis D and incidence of bone pain is known. However, the potential underlying mechanisms by which vitamin D might exert its analgesic effects are poorly understood. In this review, we discuss pathways involved in pain sensing and processing primarily at the level of dorsal root ganglion (DRG) neurons and the potential interplay between vitamin D, its receptor (VDR) and known specific pain signaling pathways including nerve growth factor (NGF), glial-derived neurotrophic factor (GDNF), epidermal growth factor receptor (EGFR), and opioid receptors. We also discuss how vitamin D/VDR might influence immune cells and pain sensitization as well as review the increasingly important topic of vitamin D toxicity. Further in vitro and in vivo experimental studies will be required to study these potential interactions specifically in pain models. Such studies could highlight the potential usefulness of vitamin D either alone or in combination with existing analgesics to better treat chronic pain.
Peritraumatic Vitamin D Levels Predict Chronic Pain Severity and Contribute to Racial Differences in Pain Outcomes Following Major Thermal Burn Injury. [2022]Major thermal burn injuries result in approximately 40,000 hospitalizations in the United States each year. Chronic pain affects up to 60% of burn survivors, and Black Americans have worse chronic pain outcomes than White Americans. Mechanisms of chronic pain pathogenesis after burn injury, and accounting for these racial differences, remain poorly understood. Due to socioeconomic disadvantage and differences in skin absorption, Black Americans have an increased prevalence of Vitamin D deficiency. We hypothesized that peritraumatic Vitamin D levels predict chronic pain outcomes after burn injury and contribute to racial differences in pain outcomes. Among burn survivors (n = 77, 52% White, 48% Black, 77% male), peritraumatic Vitamin D levels were more likely to be deficient in Blacks vs Whites (27/37 [73%] vs 14/40 [35%], P
Improvement of pain, sleep, and quality of life in chronic pain patients with vitamin D supplementation. [2022]To evaluate the effects of vitamin D supplementation in outpatient veterans with multiple areas of chronic pain.
The association between vitamin D concentration and pain: a systematic review and meta-analysis. [2023]Pain-related conditions, such as chronic widespread pain and fibromyalgia, are major burdens for individuals and the health system. Evidence from previous research on the association between circulating 25-hydroxyvitamin D (25(OH)D) concentrations and pain is conflicting. Thus, we aimed to determine if there is an association between mean 25(OH)D concentration (primary aim), or proportion of hypovitaminosis D (secondary aim), and pain conditions in observational studies.
Is there role for vitamin D in the treatment of chronic pain? [2023]Chronic pain is highly prevalent in the developed world, and levels of vitamin D are often lower among those with chronic pain conditions than those without. Supplementation of vitamin D has been investigated as a potential independent treatment for chronic pain. This paper presents an overview of the scientific evidence and provides recommendations for use of vitamin D in clinical practice with chronic pain patients.
Vitamin D deficiency in burn patients. [2018]Vitamin D deficiency has been reported in pediatric burn patients; however, no formal studies have been conducted in adult burn populations. The available literature on vitamin D status in burn patients has been reviewed. A literature search was conducted using Medline™, the Cochrane central register of controlled trials, and EMBASE to identify any trials of vitamin D deficiency in burn patients. Six published studies regarding vitamin D status in burn patients were found; however, five of these were in pediatric populations and several did not assess vitamin D levels as a major endpoint. Vitamin D deficiency has been demonstrated to result in itching, muscle weakness, and neuropathy, all of which are common postburn sequelae. The major source of vitamin D is synthesis in the skin with a small amount being absorbed through dietary intake. Population groups are at higher risk of vitamin D deficiency if they have inadequate exposure to UV light or reduced biosynthetic capability due to skin damage. Burn patients fall into both risk groups and also suffer common complaints that overlap with those reported by patients with vitamin D deficiency. Further research in adult burn patients is needed to determine the prevalence of deficiency in this population and whether vitamin D deficiency might influence postburn injury symptoms reported by patients.
Hypovitaminosis D in acutely injured pediatric burn patients. [2018]The prevalence of vitamin D insufficiency, its etiology, and associated sequelae among acutely injured burn patients is unknown.
Effect of cholecalciferol recommended daily allowances on vitamin D status and fibroblast growth factor-23: an observational study in acute burn patients. [2021]Burn patients are at risk of hypovitaminosis D. Optimal vitamin D (VD) intakes are not defined in burn nutrition guidelines and studies mostly focused on ergocalciferol (VD2) supplementation in burn children. Aim of our study was to describe adult burns VD status, to measure effects of our cholecalciferol (VD3) supplementation on VD metabolism during acute burn care, and to assess correlation between FGF23 and C-reactive protein (CRP).
Effects of cholecalciferol supplementation and optimized calcium intakes on vitamin D status, muscle strength and bone health: a one-year pilot randomized controlled trial in adults with severe burns. [2015]Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia. Vitamin D pleiotropic effects may influence bone and muscle health. The aim of this pilot study was to assess effects of a cholecalciferol (VD3) supplementation and an optimized calcium (Ca) regimen on vitamin D (VD) status, bone and muscle health during sequelar stage of burn injury.
Can vitamin D deficiency produce an unusual pain syndrome? [2022]An unusual pain occurred in five patients in the presence of compromised vitamin D status and resolved 5 to 7 days after supplementation with vitamin D in the form of ergocalciferol. The pain had a hyperesthetic quality and did not respond to the use of analgesics, including opiate derivatives. Treatment with therapeutic levels of a tricyclic antidepressant did not bring relief of symptoms. In one case, months after treatment and subsequent improvement of vitamin D status and pain, the vitamin D status again declined and the pain recurred. The pain again resolved with vitamin D replacement and improvement of levels. There may be a pain syndrome associated with vitamin D depletion that appears as hyperesthesia worsened by light, superficial pressure or even small increments of movement. This pain restricts mobility and function and may lead to further complications, such as pressure sores.
The effect of vitamin D supplementation on pain: an analysis of data from the D-Health randomised controlled trial. [2023]Observational studies suggest that 25-hydroxy vitamin D (25(OH)D) concentration is inversely associated with pain. However, findings from intervention trials are inconsistent. We assessed the effect of vitamin D supplementation on pain using data from a large, double-blind, population-based, placebo-controlled trial (the D-Health Trial). 21 315 participants (aged 60-84 years) were randomly assigned to a monthly dose of 60 000 IU vitamin D3 or matching placebo. Pain was measured using the six-item Pain Impact Questionnaire (PIQ-6), administered 1, 2 and 5 years after enrolment. We used regression models (linear for continuous PIQ-6 score and log-binomial for binary categorisations of the score, namely 'some or more pain impact' and 'presence of any bodily pain') to estimate the effect of vitamin D on pain. We included 20 423 participants who completed ≥1 PIQ-6. In blood samples collected from 3943 randomly selected participants (∼800 per year), the mean (sd) 25(OH)D concentrations were 77 (sd 25) and 115 (sd 30) nmol/l in the placebo and vitamin D groups, respectively. Most (76 %) participants were predicted to have 25(OH)D concentration >50 nmol/l at baseline. The mean PIQ-6 was similar in all surveys (∼50·4). The adjusted mean difference in PIQ-6 score (vitamin D cf placebo) was 0·02 (95 % CI (-0·20, 0·25)). The proportion of participants with some or more pain impact and with the presence of bodily pain was also similar between groups (both prevalence ratios 1·01, 95 % CI (0·99, 1·03)). In conclusion, supplementation with 60 000 IU of vitamin D3/month had negligible effect on bodily pain.