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
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:
Burns
Vitamin D Deficiency
Bone Demineralization, Pathologic
Wounds and Injuries
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014