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OpenTrials
Completed

NCT Number: NCT00536276

Evaluation of Vitamin D Status in Children With Acute Burns

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

Completed

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shriners Hospital for Children

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D2

Dietary Supplement

Daily enteral dose of 100IU/kg

Other names: ergocalciferol

Vitamin D3

Dietary Supplement

Daily enteral dose of 100IU/kg

Other names: cholecalciferol

Primary outcomes

  1. Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels

    Time frame: During acute phase postburn

Secondary outcomes

  1. Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers

    Time frame: During acute phase postburn

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Registry information

Official study title

Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention

Acronym: VitaminD

Important dates

Study start
2003
Primary completion
2009
Study completion
2011
First posted
Sep 27, 2007
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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