← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 12 months

Awards & highlights

Study 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

Select...

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

Select...

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.

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,741 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments is Ergocalciferol Capsules typically utilized to address?

"Ergocalciferol Capsules are a viable option for treating vitamin d resistant rickets, rectifying dietary deficiencies, and restoring phosphaturia."

Answered by AI

Could you detail the literature surrounding Ergocalciferol Capsules?

"Presently, 34 clinical trials survey the efficacy of Ergocalciferol Capsules; 11 are in Phase 3. Most studies for this medication take place in Dallas, Texas however there are 89 research sites across the country."

Answered by AI

Are there opportunities for individuals to join the trial at this time?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study was initially published on September 29th 2022 and has been actively recruiting ever since its last update on October 28th 2022. 70 patients need to be recruited from a single centre for the trial's completion."

Answered by AI

Has the FDA sanctioned Ergocalciferol Capsules for public use?

"Ergocalciferol Capsules have already been authorized for medical use, thus it earned a score of 3 on the safety scale."

Answered by AI

What is the scope of this trial's patient pool?

"Affirmative. Clinicaltrials.gov records verify that this clinical trial, first announced on September 29th 2022, is enrolling participants at present time. 70 patients need to be recruited from one medical institution."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D Deficiency in Adults Following a Major Burn Injury

Karen Kowalske 2022. "Vitamin D Deficiency in Adults Following a Major Burn Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05084248.

All > Vitamin D Deficiency > Vitamin D