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NCT00591604 Clinical Trial

High-Dose Vitamin D Deficiency in Burn Injury

Burn Clinical Trial

— VitaminD  

Official title:
Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00591604
Other study ID # 06-250
Secondary ID
Status Withdrawn
Phase Phase 3
First received December 26, 2007
Last updated November 13, 2012
Start date February 2007
Est. completion date March 2009

Study information
Verified date November 2012
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 18 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
Vitamin D, 50,000IU,once weekly for 8 weeks, then every other week for 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in overall bone health 12 weeks Yes
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