Vitamin D Deficiency in Adults Following a Major Burn Injury

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults, 18 years of age or older, who have completed 6 months from time of their burn injury

• ≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure

• ≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure

• Electrical high voltage / lightning and Burn Surgery for Wound Closure

• Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure

• May speak English or Spanish

• Vit. D deficiency

Locations
United States
Texas
Parkland Health and Hospital Systems
Dallas
Time Frame
Start Date: 2022-09-29
Completion Date: 2025-08-18
Participants
Target number of participants: 48
Treatments
Active_comparator: Low-dose
400 IU Per Orem
Experimental: High-dose
4000 IU Per Orem
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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