Vitamin D Deficiency in Adults Following a Major Burn Injury

NCT05084248 | Completed Phase 4 FDA Drug

• 1 other identifier: STU-2019-1223
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin D Deficiency; Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Demographics

  6 months

• Patient-Reported Outcomes Measurement Information System-Global

  6 months and 12 months

• Patient-Reported Outcomes Measurement Information System-Itch

  6 months and 12 months

Study Arms (2)

Low-dose

ACTIVE COMPARATOR

400 IU Per Orem

Drug: Ergocalciferol Capsules

High-dose

EXPERIMENTAL

4000 IU Per Orem

Drug: Ergocalciferol Capsules

Interventions

Ergocalciferol Capsules DRUG

Capsules of ergocalciferol at 400 IU and 4000 IU

Also known as: Vitamin D

High-dose; Low-dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury
• Patients with malignant tumors

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Parkland Health and Hospital Systems

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Burns

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Maria Pia Kabamalan

  UT Southwestern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 19, 2021
• Study Start: September 29, 2022
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)