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

S

Shriners Hospitals for Children

Status and phase

Completed
Phase 1

Conditions

Burns
Bone Demineralization

Treatments

Dietary Supplement: Vitamin D2
Dietary Supplement: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT00536276
01-9-26-1

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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