Status:
TERMINATED
Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury
Lead Sponsor:
Kathy Prelack, PhD, RD
Conditions:
Burn
Growth
Eligibility:
All Genders
4-18 years
Phase:
PHASE1
Brief Summary
The purpose of this study is two-fold. The first is to establish that bone mineral density is diminished among children admitted to this regional burn center as compared to healthy non-burned children...
Detailed Description
The 60 acute patients will be randomized into 4 groups. Acute patients must be enrolled within 3 weeks of their admission to be eligible for study. Treatment is defined as provision of a supplement of...
Eligibility Criteria
Inclusion
- Inclusion Criteria for acute patients:
- Patient is between ages 4 and 18 at the time of study Patients must be of Black, White or Hispanic descent Patient has sustained a 30% or greater total body surface area burn Patient is enrolled ≤ 21 days of admission to the acute unit Patient is hemodynamically stable Patient does not have a history of osteopenia Inclusion criteria for reconstructive patients Child is between ages 4 to 18 Patients have sustained a 30% or greater tbsa in the last 10 years Patients must be of Black, White or Hispanic descent Live in Northeastern USA Inclusion criteria for healthy children Child is between ages 4 to 18 Patients must be of Black, White or Hispanic descent Live in Northeastern USA Child is capable of cooperating during measurement
- Exclusion Criteria for patients and healthy children:
- Underlying complicating disorder that manifests in bone demineralization Patient or child is not expected to return to the hospital for additional follow-up or care
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00285090
Start Date
February 1 2005
End Date
February 1 2007
Last Update
December 20 2011
Active Locations (1)
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1
Shriners Burns Hospital
Boston, Massachusetts, United States, 02114