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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose | Active Comparator | 400 IU Per Orem |
|
| High-dose | Experimental | 4000 IU Per Orem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol Capsules | Drug | Capsules of ergocalciferol at 400 IU and 4000 IU |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Pia Kabamalan | UT Southwestern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health and Hospital Systems | Dallas | Texas | 75235 | United States |
Data may be shared with Burn Model System under National Institute on Disability and Rehabilitation Research.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2022 | Oct 31, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D002056 | Burns |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D014947 | Wounds and Injuries |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |