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Vitamin D Deficiency in Adults Following a Major Burn Injury

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ClinicalTrials.gov Identifier: NCT05084248
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Karen Kowalske, University of Texas Southwestern Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Burns Drug: Ergocalciferol Capsules Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency in Adults Following a Major Burn Injury
Actual Study Start Date : September 29, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Low-dose
400 IU Per Orem
 Drug: Ergocalciferol Capsules
Capsules of ergocalciferol at 400 IU and 4000 IU
Other Name: Vitamin D
Experimental: High-dose
4000 IU Per Orem
 Drug: Ergocalciferol Capsules
Capsules of ergocalciferol at 400 IU and 4000 IU
Other Name: Vitamin D


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084248


Contacts
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Contact: Kyra Jeanine Solis, BS 214-648-3560 KyraJeanine.Solis@UTSouthwestern.edu
Contact: Karen Kowalske, MD 214-645-2080 karen.kowalske@utsouthwestern.edu

Locations
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United States, Texas
Parkland Health and Hospital Systems Recruiting
Dallas, Texas, United States, 75235
Contact: Kyra Jeanine Solis, BS    214-648-3560    KyraJeanine.Solis@UTSouthwestern.edu   
Contact: Karen Kowalske, MD    214-645-2080    Karen.Kowalske@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Chair: Maria Pia Kabamalan UT Southwestern
More Information
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Responsible Party: Karen Kowalske, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05084248    
Other Study ID Numbers: STU-2019-1223
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data may be shared with Burn Model System under National Institute on Disability and Rehabilitation Research.

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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
Additional relevant MeSH terms:
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Vitamin D Deficiency
Burns
Wounds and Injuries
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents