Vitamin D Deficiency in Adults Following a Major Burn Injury

Description

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.

Conditions

Vitamin D Deficiency, Burns

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Study Overview

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Study Details

Study 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.

Vitamin D Deficiency in Adults Following a Major Burn Injury

Vitamin D Deficiency in Adults Following a Major Burn Injury

Condition
Vitamin D Deficiency
Intervention / Treatment

-

Contacts and Locations

Dallas

Parkland Health and Hospital Systems, Dallas, Texas, United States, 75235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Maria Pia Kabamalan, STUDY_CHAIR, UT Southwestern

Study Record Dates

2025-12