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NCT05084248 · ClinicalTrials.gov registry record · Phase 4
Vitamin D Deficiency in Adults Following a Major Burn Injury
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT05084248 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 48 participants.
The verdict
NCT05084248, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ergocalciferol Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2025-08-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05084248
The ClinicalTrials.gov registry entry for NCT05084248 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ergocalciferol Capsules is the first listed.
NCT05084248 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05084248 about?
NCT05084248 is a clinical study titled "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 controll...
What is the current status of trial NCT05084248?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2022-09-29. Estimated completion is 2025-08-18.
What interventions are being tested in trial NCT05084248?
The interventions under investigation include: Ergocalciferol Capsules (DRUG).
Who is sponsoring clinical trial NCT05084248?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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