Vitamin D Deficiency in Adults Following a Major Burn Injury

University of Texas Southwestern Medical Center48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Vitamin D Deficiency Burns

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months and 12 months

Secondary Outcomes

Demographics

include subject demographics, injury demographics and characteristics

Time frame: 6 months

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.

Time frame: 6 months and 12 months

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.

Time frame: 6 months and 12 months

Vitamin D Deficiency in Adults Following a Major Burn Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes