Study Stopped
Lack of volunteers
Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury
1 other identifier
interventional
60
1 country
1
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. The second purpose of this study is to examine the short and long-term effects of calcium and vitamin D supplementation in on bone metabolism and accrual in children who have been burned. Specific Aims: 1) To measure bone mineral content and bone mineral density and their change during growth in convalescent burned children admitted to a regional burn center and to compare them to normal, healthy children.; 2) To measure lean body mass, fat mass, total body water in convalescent burned children admitted to a regional burn center and compare them to normal, healthy children with focus on how these components of body composition relate to indices of bone mineral content and density; 3) To identify alterations in bone metabolism and calcium and vitamin D homeostasis following burn injury and relate these to bone mineral density in burned children; 4) To test the effect of short term calcium and vitamin D supplementation on improving bone mineral density, bone mineral content, and indices of calcium and vitamin D metabolism in acutely burned children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 31, 2006
CompletedFirst Posted
Study publicly available on registry
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 20, 2011
December 1, 2011
2 years
January 31, 2006
December 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Bone mineral density
2 mos, 6 mos (acute), then Annual
Biochemical Indicators of Vitamin D and calcium status
every 4 weeks (acute), then annual
Growth
Annual
Secondary Outcomes (1)
Lean Body Mass
2 mos, 6 mos (acute), then annual
Study Arms (4)
Early Treatment
EXPERIMENTALLateTreatment
EXPERIMENTALTotal Treatment
EXPERIMENTALNo Treatment
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Burns Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrina Prelack, PhD
Shriners Burns Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Clincal Nutrition
Study Record Dates
First Submitted
January 31, 2006
First Posted
February 1, 2006
Study Start
February 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
December 20, 2011
Record last verified: 2011-12