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drugset / Trial / NCT05084248

Vitamin D Deficiency in Adults Following a Major Burn Injury

NCT05084248 ↗

Phase 4 Completed 48 enrolled University of Texas Southwestern Medical Center National Institute on Disability, Independent Living, and Rehabilitation Research · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-09-29
Primary completion
2025-08-18
Completion
2025-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Ergocalciferol Small molecule 400 iu —
Subject Ergocalciferol Small molecule 4000 iu —

Indications

vitamin D deficiency