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Evaluation of Vitamin D Status in Children With Acute Burns (VitaminD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536276
First Posted: September 27, 2007
Last Update Posted: May 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
  Purpose
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

Condition Intervention Phase
Burns Bone Demineralization Dietary Supplement: Vitamin D2 Dietary Supplement: Vitamin D3 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention

Resource links provided by NLM:


Further study details as provided by Michele Gottschlich, Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers [ Time Frame: During acute phase postburn ]

Enrollment: 50
Study Start Date: March 2003
Study Completion Date: April 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Vitamin D2
    Daily enteral dose of 100IU/kg
    Other Name: ergocalciferol
    Dietary Supplement: Vitamin D3
    Daily enteral dose of 100IU/kg
    Other Name: cholecalciferol
Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536276


Locations
United States, Ohio
Shriners Hospital for Children
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Michele M Gottschlich, PhD, RD, CNSD Shriners Hospital for Children
  More Information

Publications:
Responsible Party: Michele Gottschlich, Director, Nutrition Services, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00536276     History of Changes
Other Study ID Numbers: 01-9-26-1
First Submitted: September 25, 2007
First Posted: September 27, 2007
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Michele Gottschlich, Shriners Hospitals for Children:
vitamin D

Additional relevant MeSH terms:
Burns
Bone Demineralization, Pathologic
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents