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High-Dose Vitamin D Deficiency in Burn Injury (VitaminD)

Primary Purpose

Burn

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn focused on measuring burn, vitamin D, nutrition, burn recovery

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Vitamin D administration

    Outcomes

    Primary Outcome Measures

    Increase in overall bone health

    Secondary Outcome Measures

    Full Information

    First Posted
    December 26, 2007
    Last Updated
    November 13, 2012
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00591604
    Brief Title
    High-Dose Vitamin D Deficiency in Burn Injury
    Acronym
    VitaminD
    Official Title
    Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    hurricane caused closure of hospital with PI not associated with Shriners Hospital for children
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burn
    Keywords
    burn, vitamin D, nutrition, burn recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Vitamin D administration
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin D
    Intervention Description
    Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks
    Primary Outcome Measure Information:
    Title
    Increase in overall bone health
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David N Herndon, MD
    Organizational Affiliation
    University of Texas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    High-Dose Vitamin D Deficiency in Burn Injury

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