Evaluation of Vitamin D Status in Children With Acute Burns

Burns Clinical Trial

— VitaminD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536276
• Other study ID #: 01-9-26-1
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2007
• Last updated: May 8, 2012
• Start date: March 2003
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Demineralization
• Burns

Intervention

Dietary Supplement:
• Vitamin D2
Daily enteral dose of 100IU/kg
• Vitamin D3
Daily enteral dose of 100IU/kg

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels		During acute phase postburn	Yes
Secondary	Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers		During acute phase postburn	Yes