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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
History of Changes

September 25, 2007
May 8, 2012
March 2003
December 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00536276 on ClinicalTrials.gov Archive Site
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 ]
Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers [ Time Frame: During acute phase postburn ]
Not Provided
Not Provided
 
Evaluation of Vitamin D Status in Children With Acute Burns
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Burns
  • Bone Demineralization
  • 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
Not Provided
Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2011
December 2009   (final data collection date for primary outcome measure)

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)
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536276
01-9-26-1
Yes
Michele Gottschlich, Shriners Hospitals for Children
Shriners Hospitals for Children
Not Provided
Principal Investigator: Michele M Gottschlich, PhD, RD, CNSD Shriners Hospital for Children
Shriners Hospitals for Children
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP