BurnPhase 3VitaminDNCT00591604
High-Dose Vitamin D Deficiency in Burn Injury
A Phase 3 study testing Vitamin D in people with Burn, run by The University of Texas Medical Branch, Galveston.
Trial summary
High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Burn
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2009
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5+ yrs
- Burn size 40% or greater
- Patient can remain around Shriner Hospital for Children area for 16 weeks
- Agree to take Vitamin D
Who cannot join
- Age less than 5yrs
- Burn size less than 40%
- Pre-existing bone disease or healing fractures
- Underlying chronic disease-endocrine or cancer
- Kidney failure
About this study
Official title: Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study
High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vitamin D administration Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in overall bone health
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: hurricane caused closure of hospital with PI not associated with Shriners Hospital for children
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591604
- Sponsor's protocol ID
- 06-250
- Acronym
- VitaminD
- Status last verified
- Nov 2012
- First submitted
- 26 Dec 2007
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study
- ClinicalTrials.gov ID
- NCT00591604
- Acronym / sponsor ID
- VitaminD / 06-250
- Conditions
- Burn
- Keywords
- burn, vitamin D, nutrition, burn recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: hurricane caused closure of hospital with PI not associated with Shriners Hospital for children
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- 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.
High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vitamin DVitamin D administration |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 5+ yrs
- Burn size 40% or greater
- Patient can remain around Shriner Hospital for Children area for 16 weeks
- Agree to take Vitamin D
Key exclusion criteria (5 listed)
- Age less than 5yrs
- Burn size less than 40%
- Pre-existing bone disease or healing fractures
- Underlying chronic disease-endocrine or cancer
- Kidney failure
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 |
|---|---|---|
| Vitamin DVitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks | Drug | 1 |
Primary outcome
Increase in overall bone health
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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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.
David N Herndon, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Burn, run by The University of Texas Medical Branch, Galveston.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Increase in overall bone health (time frame: 12 weeks). 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 Nov 2012.