High-Dose Vitamin D Deficiency in Burn Injury | NCT00591604

Studies
High-Dose Vitamin D Deficiency in Burn Injury

NCT00591604

Sponsor

The University of Texas Medical Branch, Galveston

Status

Withdrawn

Last Update Posted

Nov 15, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Burn

Interventions

Vitamin D

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

hurricane caused closure of hospital with PI not associated with Shriners Hospital for children

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2012

Last Update Posted Date

Nov 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Vitamin D administration	Drug: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks	1

Measure	Description	Time Frame
Increase in overall bone health		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

5+ yrs
Burn size 40% or greater
Patient can remain around Shriner Hospital for Children area for 16 weeks
Agree to take Vitamin D

Exclusion Criteria:

Age less than 5yrs
Burn size less than 40%
Pre-existing bone disease or healing fractures
Underlying chronic disease-endocrine or cancer
Kidney failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
David N Herndon, MD	University of Texas	Principal Investigator

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided