NCT00591604

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

2.1 years

First QC Date

December 26, 2007

Last Update Submit

November 13, 2012

Conditions

Burn

Keywords

burnvitamin Dnutritionburn recovery

Outcome Measures

Primary Outcomes (1)

  • Increase in overall bone health

    12 weeks

Study Arms (1)

1

EXPERIMENTAL

Vitamin D administration

Drug: Vitamin D

Interventions

Vitamin DDRUG

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

1

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • + yrs
  • Burn size 40% or greater
  • Patient can remain around Shriner Hospital for Children area for 16 weeks
  • Agree to take Vitamin D

You may not qualify if:

  • Age less than 5yrs
  • Burn size less than 40%
  • Pre-existing bone disease or healing fractures
  • Underlying chronic disease-endocrine or cancer
  • Kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • David N Herndon, MD

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

February 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 15, 2012

Record last verified: 2012-11