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
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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 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 |

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 |
- 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.
- Demographics [ Time Frame: 6 months ]include subject demographics, injury demographics and characteristics
- 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.
- 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.

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

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
Contact: Kyra Jeanine Solis, BS | 214-648-3560 | KyraJeanine.Solis@UTSouthwestern.edu | |
Contact: Karen Kowalske, MD | 214-645-2080 | karen.kowalske@utsouthwestern.edu |
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 |
Study Chair: | Maria Pia Kabamalan | UT Southwestern |
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. |
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 |
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 |