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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)

Must not have

Taking Vitamin D supplements in excess of 800 IU daily

Requires an emergency/bedside escharotomy or fasciotomy for the treatment of burn injury

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

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.

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.

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 below

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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.

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I am between 18 and 70 years old.

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I am currently admitted to a burn center.

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I am willing to take 6 capsules daily for the study.

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Less than 30% of my body is burned.

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Less than 30% of my body is burned.

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I have a burn injury caused by heat, not by electricity or chemicals.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 800 IU of Vitamin D supplements daily.

Select...

I need an urgent procedure to treat my burn injury.

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My kidney function is severely reduced.

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My liver disease is classified as moderate to severe.

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I am currently on a breathing machine and sedated.

Select...

I have been diagnosed with sarcoidosis.

Select...

I have a serious injury, like a broken long bone.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Burn injury

Secondary study objectives

25-hydroxyvitamin D concentration 6 weeks after Vitamin D2 treatment

By Group Efficacy Estimates Over Year Following Thermal Burn Injury

Neuralgia

+5 more

Other study objectives

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.

0 / 15Eligibility criteria met