Overview

Vitamin D Deficiency in Adults Following a Major Burn Injury

Status:
Not yet recruiting

Trial end date:
2024-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Texas Southwestern Medical Center

Treatments:

Ergocalciferols
Vitamin D

Criteria

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