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Completed

NCT Number: NCT05084248

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Burns Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parkland Health and Hospital Systems

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Ergocalciferol Capsules

Drug

Capsules of ergocalciferol at 400 IU and 4000 IU

Other names: Vitamin D

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System-29

    Time frame: 6 months and 12 months

    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.

Secondary outcomes

  1. Demographics

    Time frame: 6 months

    include subject demographics, injury demographics and characteristics

  2. Patient-Reported Outcomes Measurement Information System-Global

    Time frame: 6 months and 12 months

    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.

  3. Patient-Reported Outcomes Measurement Information System-Itch

    Time frame: 6 months and 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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