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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00536276
First received: September 25, 2007
Last updated: May 8, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers [ Time Frame: During acute phase postburn ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 25, 2007
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
vitamin D

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

ClinicalTrials.gov processed this record on November 25, 2014