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Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury

NCT00285090 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-12-20

No results posted yet for this study

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.

Conditions

  • Burn
  • Growth
  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Calcium, Vitamin D

DIETARY_SUPPLEMENT

Calcium,Vitamin D

DIETARY_SUPPLEMENT

Calcium, VitaminD

OTHER

Sugar Pill

Sponsors & Collaborators

  • Kathy Prelack, PhD, RD

    lead OTHER

Principal Investigators

  • Kathrina Prelack, PhD · Shriners Burns Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00285090 on ClinicalTrials.gov