Vitamin D Deficiency in Adults Following a Major Burn Injury

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Vitamin D Deficiency; Burns

Treatments: Drug: Ergocalciferol Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05084248

STU-2019-1223

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Low-dose

Active Comparator group

Description:

400 IU Per Orem

Treatment:

Drug: Ergocalciferol Capsules

High-dose

Experimental group

Description:

4000 IU Per Orem

Treatment:

Drug: Ergocalciferol Capsules