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Vitamin D
Vitamin D for Chronic Pain After Burns
Phase 2
Recruiting
Led By Matthew Mauck, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients experience a thermal burn injury, not an electrical or chemical burn.
Burn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by the patient on screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
Awards & highlights
Study Summary
This trial will study if Vitamin D can reduce chronic pain after burn injury, and examine its effects on the immune system. Participants will take pills, provide blood samples and answer surveys.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include high calcium levels in the blood which could cause weakness, confusion, or digestive issues. However, since it's a vitamin supplement at controlled doses, serious side effects are considered unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My burn injury is caused by heat, not electricity or chemicals.
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I am a burn survivor with pain level of 7 or more out of 10.
Select...
I am between 18 and 70 years old.
Select...
I am currently admitted to a burn center.
Select...
I am willing to take 6 capsules daily for the study.
Select...
Less than 30% of my body is burned.
Select...
Less than 30% of my body is burned.
Select...
I have a burn injury caused by heat, not by electricity or chemicals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Burn injury
Secondary outcome measures
25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment
By Group Efficacy Estimates Over Year Following Thermal Burn Injury
Neuralgia
+5 moreOther outcome measures
Inflammatory immune cells populations assessed with mass cytometry
Trial Design
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.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,002 Total Patients Enrolled
7 Trials studying Burns
629 Patients Enrolled for Burns
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,933 Total Patients Enrolled
Matthew Mauck, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have high levels of phosphorus in your blood.You have high levels of calcium in your blood.I am mentally alert and aware of my surroundings.My burn injury is caused by heat, not electricity or chemicals.I take more than 800 IU of Vitamin D supplements daily.You have had a working smartphone for more than a year.I am a burn survivor with pain level of 7 or more out of 10.I am between 18 and 70 years old.I am currently admitted to a burn center.I need an urgent procedure to treat my burn injury.My kidney function is severely reduced.I am willing to take 6 capsules daily for the study.My liver disease is classified as moderate to severe.My surgical team has a plan for treating my burn wound, possibly using grafts.You are allergic to Vitamin D3 or other related medications.I am currently on a breathing machine and sedated.I have been diagnosed with sarcoidosis.Less than 30% of my body is burned.Less than 30% of my body is burned.I have a serious injury, like a broken long bone.You are currently experiencing severe mental health issues, including thinking about hurting yourself or others.I have a burn injury caused by heat, not by electricity or chemicals.Your vitamin D level is less than 100 ng/ml when tested at the clinic.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D2 (Ergocalciferol)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How do I sign-up for this chance to participate in this research?
"The inclusion criteria for this trial requires that patients have suffered a burn injury and are between 18-65 years old. So far, 40 people have been recruited into the study."
Answered by AI
Are researchers actively looking for new participants for this trial?
"According to the latest update on clinicaltrials.gov, this trial is not currently looking for patients. This study was first posted on November 1st, 2022 and was last edited less than a week ago on the 8th. There are 499 other trials that are open for enrollment at this time."
Answered by AI
What is the FDA's opinion on Vitamin D2 for public consumption?
"There is limited data to support the efficacy of Vitamin D2 (Ergocalciferol), but it has received a score of 2 due to the clinical evidence affirming its safety."
Answered by AI
Does this research project allow people who are over 35 years old to participate?
"The age range that this clinical trial is willing to accept patients is those who are 18 years old or above, and 65 years old or below."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
University Of North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
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