Vitamin D DeficiencyPhase 4NCT05084248
Vitamin D Deficiency in Adults Following a Major Burn Injury
A Phase 4 study testing Ergocalciferol Capsules in people with Vitamin D Deficiency and Burns, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Burns
- What is being tested?
- Ergocalciferol Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 18 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital Systems
Dallas, Texas, 75235
About this study
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.
- Conditions
- Vitamin D Deficiency, Burns
- Being tested
- Ergocalciferol Capsules
- Medical subject headings
- Vitamin D Deficiency, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol CapsulesDrug
Also called Vitamin D
Capsules of ergocalciferol at 400 IU and 4000 IU
| Study group | Role | What they receive |
|---|---|---|
| Low-dose | Active comparator | 400 IU Per Orem Receives: Drug: Ergocalciferol Capsules |
| High-dose | Experimental | 4000 IU Per Orem Receives: Drug: Ergocalciferol Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months and 12 months
Secondary outcomes (3)
Demographics
include subject demographics, injury demographics and characteristics
Measured: 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.
Measured: 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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start29 Sep 2022
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Karen Kowalske, University of Texas Southwestern Medical Center
- Investigators
- Maria Pia Kabamalan, Study chair, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084248
- Sponsor's protocol ID
- STU-2019-1223
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared with Burn Model System under National Institute on Disability and Rehabilitation Research.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Adults Following a Major Burn Injury
- ClinicalTrials.gov ID
- NCT05084248
- Acronym / sponsor ID
- STU-2019-1223
- Conditions
- Vitamin D Deficiency, Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose | Active comparator | Drug: Ergocalciferol Capsules400 IU Per Orem |
| High-dose | Experimental | Drug: Ergocalciferol Capsules4000 IU Per Orem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergocalciferol CapsulesAlso: Vitamin DCapsules of ergocalciferol at 400 IU and 4000 IU | Drug | High-dose, Low-dose |
Primary outcome
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.
3 secondary outcomes
Demographics
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System-Global
Time frame: 6 months and 12 months
Patient-Reported Outcomes Measurement Information System-Itch
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. Data may be shared with Burn Model System under National Institute on Disability and Rehabilitation Research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Pia Kabamalan study chair
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol Capsules in people with Vitamin D Deficiency and Burns, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System-29 (time frame: 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.