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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: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT05084248 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the finished NCT05084248 record still lists
NCT05084248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Ergocalciferol Capsules is the first listed.
NCT05084248 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05084248's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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