40 Participants Needed

Vitamin D for Chronic Pain After Burns

MM
Overseen ByMatthew Mauck
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of North Carolina, Chapel Hill
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.14678

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.1691011

Who Is on the Research Team?

MM

Matthew C Mauck, MD PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.
See 9 more

Exclusion Criteria

Prisoner status
You have high levels of phosphorus in your blood.
You have high levels of calcium in your blood.
See 11 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

  • Ergocalciferol
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Vitamin D2 (Ergocalciferol)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Ergocalciferol is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Ergocalciferol for:
🇪🇺
Approved in European Union as Ergocalciferol for:
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Approved in Canada as Ergocalciferol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Published Research Related to This Trial

Chronic pain affects about 50 million adults in the U.S., and current pain medications are often ineffective for many, with around 20% of patients experiencing no relief.
Vitamin D may offer a promising alternative for managing chronic pain due to its potential analgesic effects, which could involve interactions with pain signaling pathways and immune responses, although more research is needed to fully understand these mechanisms.
Vitamin D and Its Potential Interplay With Pain Signaling Pathways.Habib, AM., Nagi, K., Thillaiappan, NB., et al.[2021]
In a study of 77 burn survivors, it was found that Black Americans had significantly lower peritraumatic Vitamin D levels compared to White Americans, with 73% of Black participants being Vitamin D deficient versus 35% of White participants.
Lower peritraumatic Vitamin D levels were linked to worse chronic pain outcomes after burn injuries, suggesting that Vitamin D deficiency may contribute to racial disparities in pain experiences among burn survivors.
Peritraumatic Vitamin D Levels Predict Chronic Pain Severity and Contribute to Racial Differences in Pain Outcomes Following Major Thermal Burn Injury.Mauck, MC., Barton, CE., Tungate, A., et al.[2022]
A study involving 28 veterans with chronic pain and low vitamin D levels showed that standardized vitamin D supplementation significantly improved pain, sleep quality, and overall quality of life without any reported side effects.
Participants experienced notable improvements in pain scores, sleep latency, sleep duration, bodily pain, general health, vitality, and social functioning, indicating that vitamin D may play a beneficial role in managing chronic pain conditions.
Improvement of pain, sleep, and quality of life in chronic pain patients with vitamin D supplementation.Huang, W., Shah, S., Long, Q., et al.[2022]

Citations

Vitamin D and Its Potential Interplay With Pain Signaling Pathways. [2021]
Peritraumatic Vitamin D Levels Predict Chronic Pain Severity and Contribute to Racial Differences in Pain Outcomes Following Major Thermal Burn Injury. [2022]
Improvement of pain, sleep, and quality of life in chronic pain patients with vitamin D supplementation. [2022]
The association between vitamin D concentration and pain: a systematic review and meta-analysis. [2023]
Is there role for vitamin D in the treatment of chronic pain? [2023]
Vitamin D deficiency in burn patients. [2018]
Hypovitaminosis D in acutely injured pediatric burn patients. [2018]
Effect of cholecalciferol recommended daily allowances on vitamin D status and fibroblast growth factor-23: an observational study in acute burn patients. [2021]
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]
10.United Statespubmed.ncbi.nlm.nih.gov
Can vitamin D deficiency produce an unusual pain syndrome? [2022]
The effect of vitamin D supplementation on pain: an analysis of data from the D-Health randomised controlled trial. [2023]
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