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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

Summary

This trial is to see if replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily) has an effect on physical, mental, and social health.

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.Check my eligibility
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.See study design
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.
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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:
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I have severe liver or kidney problems not caused by a burn injury.
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I have a cancerous tumor.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-Reported Outcomes Measurement Information System-29
Secondary outcome measures
Demographics
Patient-Reported Outcomes Measurement Information System-Global
Patient-Reported Outcomes Measurement Information System-Itch

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

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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,058 Previous Clinical Trials
1,055,053 Total Patients Enrolled
7 Trials studying Burns
228 Patients Enrolled for Burns
Maria Pia KabamalanStudy ChairUT Southwestern

Media Library

Ergocalciferol Capsules (Vitamin D Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05084248 — Phase 4
Burns Research Study Groups: Low-dose, High-dose
Burns Clinical Trial 2023: Ergocalciferol Capsules Highlights & Side Effects. Trial Name: NCT05084248 — Phase 4
Ergocalciferol Capsules (Vitamin D Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084248 — Phase 4
~3 spots leftby Sep 2024