Vitamin D Deficiency in Adults Following a Major Burn Injury

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 Overview

• Status: Completed
• Conditions: Burns; Vitamin D Deficiency
• Intervention / Treatment: Drug: Ergocalciferol Capsules

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-dose; 400 IU Per Orem	Drug: Ergocalciferol Capsules; Capsules of ergocalciferol at 400 IU and 4000 IU; Other Names: Vitamin D
Experimental: High-dose; 4000 IU Per Orem	Drug: Ergocalciferol Capsules; Capsules of ergocalciferol at 400 IU and 4000 IU; Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	include subject demographics, injury demographics and characteristics	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.	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.	6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Study Chair: Maria Pia Kabamalan, UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency; Burns; Lipids; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Cholestenes; Cholestanes; Sterols; Secosteroids; Membrane Lipids; Vitamin D; Ergocalciferols
• Other Study ID Numbers: STU-2019-1223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be shared with Burn Model System under National Institute on Disability and Rehabilitation Research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes