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High-Dose Vitamin D Deficiency in Burn Injury

NCT ID: NCT00591604

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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Conditions

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Burn

Keywords

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burn vitamin D nutrition burn recovery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Vitamin D administration

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Interventions

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Vitamin D

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David N Herndon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Countries

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United States

Other Identifiers

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06-250

Identifier Type: -

Identifier Source: org_study_id