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

This study has been withdrawn prior to enrollment.
(hurricane caused closure of hospital with PI not associated with Shriners Hospital for children)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591604
First Posted: January 11, 2008
Last Update Posted: November 15, 2012
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.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose
High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.

Condition Intervention Phase
Burn Drug: Vitamin D Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Medical Branch, Galveston:

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

Enrollment: 0
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vitamin D administration
Drug: Vitamin D
Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00591604


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

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00591604     History of Changes
Other Study ID Numbers: 06-250
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by The University of Texas Medical Branch, Galveston:
burn
vitamin D
nutrition
burn recovery

Additional relevant MeSH terms:
Burns
Vitamin D Deficiency
Wounds and Injuries
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents