Vitamin D Deficiency in Adults Following a Major Burn Injury

Phase 4

Recruiting

• Conditions: Vitamin D Deficiency; Burns
• Interventions: Drug: Ergocalciferol Capsules

• Registration Number: NCT05084248
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-19
• Study Start: 2022-09-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose	Ergocalciferol Capsules	400 IU Per Orem
High-dose	Ergocalciferol Capsules	4000 IU Per Orem

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System-29	6 months and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Demographics	6 months	include subject demographics, injury demographics and characteristics
Patient-Reported Outcomes Measurement Information System-Global	6 months and 12 months	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.
Patient-Reported Outcomes Measurement Information System-Itch	6 months and 12 months	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.

Trial Locations

Locations (1)

Parkland Health and Hospital Systems; 🇺🇸 Dallas, Texas, United States