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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00591604
First received: December 26, 2007
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Burns Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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

Primary Outcome Measures:
  • Increase in overall bone health [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591604

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

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00591604     History of Changes
Other Study ID Numbers: 06-250
Study First Received: December 26, 2007
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013