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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591604
Recruitment Status : Withdrawn (hurricane caused closure of hospital with PI not associated with Shriners Hospital for children)
First Posted : January 11, 2008
Last Update Posted : November 15, 2012
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Burn Drug: Vitamin D Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study
Study Start Date : February 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 1
Vitamin D administration
Drug: Vitamin D
Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks

Primary Outcome Measures :
  1. Increase in overall bone health [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591604

Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
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Principal Investigator: David N Herndon, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00591604     History of Changes
Other Study ID Numbers: 06-250
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012
Keywords provided by The University of Texas Medical Branch, Galveston:
vitamin D
burn recovery
Additional relevant MeSH terms:
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Vitamin D Deficiency
Wounds and Injuries
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents