Burn InjuryPhase 2NCT05619289
Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn
A Phase 2 study testing Ergocalciferol in people with Burn Injury and Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burn Injury, Chronic Pain
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 16 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
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- 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%
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of North Carolina
Chapel Hill, North Carolina, 27517
About this study
Official title: Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn
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?
Read more
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.
- Conditions
- Burn Injury, Chronic Pain
- Being tested
- Ergocalciferol, Placebo
- Medical subject headings
- Burns, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Vitamin D2, Calciferol, Drisdol
One-time, oral dose of 300,000 IU of Ergocalciferol administered via 6 capsules.
PlaceboDrug
One-time, oral dose of 6 inert capsules matched to the active comparator
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 (Ergocalciferol) | Active comparator | 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. Receives: Drug: Ergocalciferol |
| Placebo | Placebo comparator | One time, oral dose of 6 placebo capsules filled with inert powder and encapsulated and masked to be indistinguishable from active comparator. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up rate 6 weeks following burn injury
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.
Measured: 6 weeks
Secondary outcomes (8)
25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment
Measure the ability of Vitamin D administration to generate sustained increases in whole-blood Vitamin D concentrations (nanograms per deciliter (ng/dl), between baseline and 6 weeks. 25-hydroxyvitamin D concentration will be determined by performing mass spectroscopy on blood spot cards collected at enrollment and at 6 weeks to determine circulating Vitamin D concentration in ng/dl. Mean concentration change from baseline and 6 weeks will be reported for participants in the placebo and intervention group.
Measured: Baseline, 6 weeks
Safety of Vitamin D2 administration in aftermath of burn injury
To assess safety, adverse events will be tracked through surveys during the 6 weeks after treatment to assess side effects and safety profile of Vitamin D. Adverse Events will be reported using Common Terminology Criteria for Adverse Events (CTCAE). Events will be graded in severity with grade 3 representing severe, grade 4 representing life-threatening, and grade 5 representing death. Relatedness will be categorized as unrelated, unlikely, possible, probable, definite. For this safety measure, we will report the number of grade 3 or higher severity and probable or higher relatedness in the placebo and intervention groups.
Measured: 6 weeks
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Preliminary estimates of efficacy (95% confidence intervals) 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 6 months following burn injury) will be entered into a linear mixed model, and overall effect estimates (beta coefficients) among groups will be determined. Unadjusted values will be reported as well as after for adjusting for baseline psychosocial factors (pain catastrophizing, anxiety, depression, stress, perceived social support), sociodemographic factors (age, sex, ethnicity, income, education attainment), and wound healing-related factors. This will be reported over the study period.
Measured: Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
Opioid cessation
Opioid cessation will be defined as the date in which opioids are discontinued for three consecutive days. Median time (days) to opioid cessation will be reported for the treatment and placebo groups.
Measured: 6 months
Neuropathic pain quality
Use NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Neuropathic pain quality to assesses to what degree (from"not at all" to " very much") the respondent's pain shows qualities typical of neuropathic pain in the past 7 days using a 1-5 scale, where 1 indicates "not at all" and 5 indicates "very much." The total scale represented on a scale from 5-25 with 25 representing the highest level of neuropathic pain. This total scale value will be reported for placebo and intervention groups 6 months following treatment.
Measured: 6 months
Pain Interference
Use NIH PROMIS Pain interference to determine the extent to which pain interferes with life function. Participants are assessed the degree to which pain interferes with life function across 8 domains. The participants rates interference on a scale of 1 to 5 with 1 representing no interference and 5 representing the maximum interference. The total scale represented on a scale of 8-40 with 40 representing the most interference. Raw scores will be converted to a T score with standard error represented in the derived measure look-up table provided by the NIH PROMIS website. T-scores will be reported for the placebo and intervention groups 6 months following treatment.
Measured: 6 months
Widespread pain severity
Regional Pain Scale (RPS) will be used to assesses pain presence (yes=1, no=0), and severity if present using a 0-10 numeric rating scale. 0-10 scale where 0 indicates no pain and 10 is the worst pain imaginable, for each location of the body (right arm, right, leg, trunk, etc). The mean number of body regions reported as painful (numeric rating scale greater than or equal to 4) will be reported for placebo and intervention groups.
Measured: 6 months
Nociceptive quality
Nociceptive quality of pain will be determined with the NIH PROMIS Nociceptive Pain Quality. Assesses to what degree (from"not at all" to " very much") the respondent's pain shows qualities typical of nociceptive pain in the past 7 days using a 1-5 scale, where 1 indicates "not at all" and 5 indicates "very much." The total scale represented on a scale from 5-25 with 25 representing the highest level of nociceptive pain. Mean total score will be reported for placebo and intervention groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start12 Apr 2023
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Matthew Mauck, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619289
- Sponsor's protocol ID
- 22-1310
- Other IDs
- K23AT011389-01A1
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared on request 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 the University of North Carolina (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Mechanisms of Vitamin D in a Randomized Controlled Trial to Reduce Chronic Pain After Burn
- ClinicalTrials.gov ID
- NCT05619289
- Acronym / sponsor ID
- 22-1310
- Conditions
- Burn Injury, Chronic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 (Ergocalciferol) | Active comparator | Drug: ErgocalciferolOne 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. |
| Placebo | Placebo comparator | Drug: PlaceboOne time, oral dose of 6 placebo capsules filled with inert powder and encapsulated and masked to be indistinguishable from active comparator. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgocalciferolAlso: Vitamin D2, Calciferol, DrisdolOne-time, oral dose of 300,000 IU of Ergocalciferol administered via 6 capsules. | Drug | Vitamin D2 (Ergocalciferol) |
| PlaceboOne-time, oral dose of 6 inert capsules matched to the active comparator | Drug | Placebo |
Primary outcome
Follow-up rate 6 weeks following burn injury
Time frame: 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.
8 secondary outcomes
25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment
Time frame: Baseline, 6 weeks
Safety of Vitamin D2 administration in aftermath of burn injury
Time frame: 6 weeks
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Time frame: Baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
Opioid cessation
Time frame: 6 months
Neuropathic pain quality
Time frame: 6 months
Pain Interference
Time frame: 6 months
Widespread pain severity
Time frame: 6 months
Nociceptive quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared on request 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 the University of North Carolina (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Mauck, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ergocalciferol in people with Burn Injury and Chronic Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up rate 6 weeks following burn injury (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.