Evaluation of Vitamin D Status in Children With Acute Burns

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2011-04-30

Brief Summary

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To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

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Detailed Description

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The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Conditions

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Burns Bone Demineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Vitamin D2

Daily enteral dose of 100IU/kg

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

Daily enteral dose of 100IU/kg

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ergocalciferol cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* Child is \> 6 months of age but \< 19 years old
* Burn injury \> 30% total body surface area
* Admitted to SHC within 4 days of injury
* Attending physician decision that patient is likely to survive
* Parents or legal guardian give informed consent along with assent of the child as applicable

Exclusion Criteria

* Attending physician decision that patient is not likely to survive
* Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (\>1000 IU/D)

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No