High-Dose Vitamin D Deficiency in Burn Injury - Full Text View

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

This study is ongoing, but not recruiting participants.

First Received: December 26, 2007 Last Updated: February 19, 2009 History of Changes

Sponsored by:	The University of Texas, Galveston
Information provided by:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT00591604

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 III

MedlinePlus related topics: Burns

Drug Information available for: Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Locations

United States, Texas
Shriners Burns Hospital
Galveston, Texas, United States, 77550

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:	University of Texas Medical Branch ( David N. Herndon, MD )
Study ID Numbers:	06-250
Study First Received:	December 26, 2007
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00591604 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:

burn
vitamin d
nutrition
burn recovery

Study placed in the following topic categories:

Vitamin D Deficiency
Burns
Avitaminosis
Wounds and Injuries
Disorders of Environmental Origin
Bone Density Conservation Agents
Trace Elements

Malnutrition
Vitamin D
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

Additional relevant MeSH terms:

Burns
Vitamin D Deficiency
Avitaminosis
Growth Substances
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Bone Density Conservation Agents

Pharmacologic Actions
Malnutrition
Vitamin D
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

ClinicalTrials.gov processed this record on May 07, 2009