What side effects are associated with this type of intervention?

Common treatments for burns include wound care, pain management, antibiotics, and nutritional support. High-dose Vitamin D (4000 IU), which is being studied for its potential benefits in modulating immune function, reducing inflammation, and aiding skin repair, can have side effects such as hypercalcemia, which may lead to nausea, vomiting, weakness, and kidney complications. Other treatments like prolonged glucocorticoid therapy can cause growth retardation, Cushingoid appearance, and osteoporosis. Methotrexate, used as a steroid-sparing agent, may cause liver toxicity, bone marrow suppression, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved various treatments for burns that focus on immune modulation, inflammation reduction, and skin repair. These include topical agents like silver sulfadiazine, which has antimicrobial properties and helps prevent infections in burn wounds. Additionally, treatments such as collagenase ointment aid in debridement and promote healing. While high-dose Vitamin D (4000 IU) specifically for burn treatment is still under investigation, its role in modulating immune function and inflammation suggests potential benefits in enhancing skin repair and recovery in burn patients.

What other types of research exist?

Promising alternatives to high-dose Vitamin D for burn patients include photodynamic therapy, which enhances skin repair and modulates immune response, and probiotics, which can reduce inflammation and improve gut health, potentially aiding in overall recovery. Additionally, dietary supplements like essential fatty acids and evening primrose oil have shown benefits in skin conditions and may support skin repair and reduce inflammation in burn patients.

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Vitamin D Supplement

Vitamin D Supplementation for Vitamin D Deficiency

Phase 4

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Electrical high voltage / lightning and Burn Surgery for Wound Closure

≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure

Must not have

Patients with parathyroid disease, severe liver dysfunction, severe kidney dysfunction, which are not caused by the burn injury

Patients with malignant tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if giving burn patients with low Vitamin D a higher amount of Vitamin D improves their health more than a smaller amount. The study focuses on physical, mental, and social health outcomes. Vitamin D deficiency is common in burn patients, and previous studies have shown that supplementation may improve health outcomes.

Who is the study for?

This trial is for adults with major burn injuries who have a vitamin D deficiency. Eligible participants are those aged 18-64 with burns covering at least 20% of their body, or those aged 65 and older with at least 10% coverage. They must be past the six-month mark from their injury and able to speak English or Spanish. People with cancer, parathyroid disease, severe liver or kidney dysfunction unrelated to burns cannot join.

What is being tested?

The study tests two doses of Vitamin D (400 IU vs. 4000 IU daily) in burn patients deficient in Vitamin D. It's a double-blind trial where neither the researchers nor participants know who gets which dose until after the results are collected. The main focus is on how these doses affect physical, mental, and social health as well as itchiness related to burns.

What are the potential side effects?

While not specified here, typical side effects of high-dose Vitamin D can include nausea, vomiting, constipation, weakness, and more serious issues like kidney damage if taken excessively over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for wounds caused by electrical or lightning injuries.

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I am between 18 and 64 years old with burns covering 20% or more of my body, and I need surgery for wound closure.

Select...

I have burns on my hand, face, or feet and need surgery for wound closure.

Exclusion Criteria

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

Select...

I have severe liver or kidney problems not caused by a burn injury.

Select...

I have a cancerous tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 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

Patient-Reported Outcomes Measurement Information System-29

Secondary study objectives

Demographics

Patient-Reported Outcomes Measurement Information System-Global

Patient-Reported Outcomes Measurement Information System-Itch

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-doseExperimental Treatment1 Intervention

4000 IU Per Orem

Group II: Low-doseActive Control1 Intervention

400 IU Per Orem

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ergocalciferol Capsules

2022

Completed Phase 4

~70

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High-dose Vitamin D (4000 IU) plays a crucial role in the treatment of burns by modulating immune function, reducing inflammation, and promoting skin repair. Vitamin D enhances the body's immune response, which is vital for preventing infections in burn wounds. It also has anti-inflammatory properties that help reduce the excessive inflammatory response often seen in burn injuries, thereby minimizing tissue damage. Additionally, Vitamin D supports the regeneration and repair of skin cells, accelerating the healing process. These mechanisms are particularly important for burn patients as they help improve recovery outcomes and reduce complications associated with severe burns.

Effects of high-dose vitamin C administration on postburn microvascular fluid and protein flux.