Burns, Bone Demineralization
Conditions
Keywords
vitamin D
Brief summary
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
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.
Interventions
DIETARY_SUPPLEMENTVitamin D2
Daily enteral dose of 100IU/kg
DIETARY_SUPPLEMENTVitamin D3
Daily enteral dose of 100IU/kg
Sponsors
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels | During acute phase postburn |
Secondary
| Measure | Time frame |
|---|---|
| Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers | During acute phase postburn |
Countries
United States
Outcome results
None listed