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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014