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

This study has been terminated.
(Lack of volunteers)
Sponsor:
Information provided by (Responsible Party):
Kathy Prelack, PhD, RD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00285090
First received: January 31, 2006
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Burn
Growth
Malnutrition
Dietary Supplement: Calcium, Vitamin D
Dietary Supplement: Calcium,Vitamin D
Dietary Supplement: Calcium, VitaminD
Other: Sugar Pill
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 2 mos, 6 mos (acute), then Annual ] [ Designated as safety issue: No ]
  • Biochemical Indicators of Vitamin D and calcium status [ Time Frame: every 4 weeks (acute), then annual ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: Annual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lean Body Mass [ Time Frame: 2 mos, 6 mos (acute), then annual ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Treatment Dietary Supplement: Calcium, Vitamin D
Experimental: LateTreatment Dietary Supplement: Calcium,Vitamin D
Experimental: Total Treatment Dietary Supplement: Calcium, VitaminD
Placebo Comparator: No Treatment Other: Sugar Pill

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 1000 mg elemental calcium with 400 IU of vitamin D daily as available in our standard hospital formulary and deemed appropriate by the pharmacist. Group 1 will take the supplement of from the day of enrollment in the study to the time of wound closure. Each group will consist of 15 patients. Upon enrollment into the study, 10 mL of blood will be obtained to measure baseline 25 and 1,25 vitamin D, parathyroid hormone, alkaline phosphatase, vitamin D binding protein, tumor necrosis factor, and IL-6 . The patients will be randomized into one of 4 groups: the early treatment group (Group 1), late treatment group (Group 2), total treatment group (Group 3) and the no treatment group (Group 4). Group 1 will take a supplement of 1000 mg calcium with 400 IU of vitamin D daily during their early acute phase of care (from the day of enrollment in the study until the time of wound closure). Group 2 will take the supplement during their rehabilitation phase of care (from the time of wound closure to the time of discharge). Group 3 will take the supplement for the entire duration of their stay (from the time of enrollment into the study to the time of discharge). Group 4 will receive no supplement. Patients who have a DXA scan of less than -2 SD units and who are in a group that is not receiving a supplement at that time (Groups 1 or 4), will begin supplementation (1000 mg calcium and 400 international units vitamin D) as part of routine care. They will remain in the study for monitoring and reporting of results. Blood levels as described above for baseline assessment will be repeated every 4 weeks for all acute patients during their initial hospital admission. At the time of wound closure, all acute patients will have their bone mineral content, bone mineral density, lean body mass, fat mass and total body water measured. This will be repeated immediately prior to discharge and at their next 2 planned reconstructive admissions (approximately 6 months to 1 year; and again at 2 years). A 10 mL blood draw to measure biochemical indices as described above will be obtained during these repeat hospital admissions as well.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285090

Locations
United States, Massachusetts
Shriners Burns Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Kathy Prelack, PhD, RD
Investigators
Principal Investigator: Kathrina Prelack, PhD Shriners Burns Hospital
  More Information

No publications provided

Responsible Party: Kathy Prelack, PhD, RD, Director of Clincal Nutrition, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00285090     History of Changes
Other Study ID Numbers: 2004-P-001850/4
Study First Received: January 31, 2006
Last Updated: December 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Burn Injury
Calcium
Vitamin D
Bone Mineral Density

Additional relevant MeSH terms:
Burns
Malnutrition
Wounds and Injuries
Nutrition Disorders
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014