Vitamin D Deficiency in Adults Following a Major Burn Injury

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Deficiency in Adults Following a Major Burn Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084248
• Other study ID #: STU-2019-1223
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2022
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Kyra Jeanine Solis, BS
• Phone: 214-648-3560
• Email: KyraJeanine.Solis[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical. Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults, 18 years of age or older, who have completed 6 months from time of their burn injury

2. = 10% TBSA, = 65 years of age and Burn Surgery for Wound Closure

3. = 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure

4. Electrical high voltage / lightning and Burn Surgery for Wound Closure

5. Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure

6. May speak English or Spanish

7. Vit. D deficiency

Exclusion Criteria:

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

2. Patients with malignant tumors

3. Patients not meeting the inclusion criteria

Related Conditions & MeSH terms

• Burns
• Vitamin D Deficiency

Intervention

Drug:
• Ergocalciferol Capsules
Capsules of ergocalciferol at 400 IU and 4000 IU

Locations

Country	Name	City	State
United States	Parkland Health and Hospital Systems	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcomes Measurement Information System-29	Measures change in physical health, mental health and social health between time points.; When the scores are transformed into t-score metric, all PROMIS measures range from 0-100. For each domain, the higher scores indicate more of what is being measured. Therefore, higher scores on anxiety indicate more anxiety, while higher scores on physical function indicate higher physical function. Please see more information here: https://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis.	6 months and 12 months
Secondary	Demographics	include subject demographics, injury demographics and characteristics	6 months
Secondary	Patient-Reported Outcomes Measurement Information System-Global	Measures change in emotional, physical, and social health between timepoints.; When the scores are transformed into t-score metric, all PROMIS measures range from 0-100. For each domain, the higher scores indicate more of what is being measured. Therefore, higher scores indicates a higher global health.	6 months and 12 months
Secondary	Patient-Reported Outcomes Measurement Information System-Itch	Measures change in itch between timepoints. When the scores are transformed into t-score metric, all PROMIS measures range from 0-100. For each domain, the higher scores indicate more of what is being measured. Therefore, higher scores indicate more itch.	6 months and 12 months