Vitamin D Deficiency in Adults Following a Major Burn Injury

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Deficiency in Adults Following a Major Burn Injury

Conditions
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Vitamin D Deficiency, Burns

Intervention / Treatment
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* Drug: Ergocalciferol Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |