Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury
| Status: | Archived |
|---|---|
| Conditions: | Food Studies, Hospital |
| Therapuetic Areas: | Pharmacology / Toxicology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
We hypothesize that bone mineral content is diminished in children aged 4-18 following burn
injury. This is based on data in burned children in other regional hospitals as well as
findings in our own population of marginal growth delay following burn injury. Our
objectives are two-fold. The first goal is to establish that diminished bone mineral density
is a long-term problem among children admitted to this regional burn hospital as compared to
healthy children in the region. This is important particularly since bone health may be
region specific, or may even relate to modes of care that vary from hospital to hospital
during the acute and convalescent phases of injury. There is no data on bone mineral
density in burned children in regions outside of the Southwestern portion of the USA. Also,
comparisons to healthy children living in this region using the same scanning machine are
needed.
The second purpose of this study is to test the effects of calcium and vitamin D
supplementation in burned children on bone accrual in burned children. In this 2-year study,
children aged 4-18 who have been previously burned will take either a calcium supplement
with vitamin D or a placebo for one year. We will evaluate patients every 6 months for 2
years (patients will be measured 6 months and 1 year after the 1 year treatment to find out
if the supplement group maintained any increase in bone formation that occurred during the
1-year treatment.
The study population will involve 60 children admitted to Shriners Burns Hospital-Boston for
reconstructive surgery and a convenience sample of 30 non-patient healthy children matched
for age and sex. The 60 patients will be randomized into 2 groups. Each group will consist
of 30 patients. Upon enrollment into the study, all patients will have their bone mineral
content, bone mineral density, lean body mass, fat mass and total body water measured. At
the time of intravenous line placement for their reconstructive surgery, 10 mL of blood will
be obtained to measure total and ionized calcium, 25 and 1,25 vitamin D, parathyroid
hormone, alkaline phosphatase, and calcitonin. The patients will be randomized into one of
2 groups (by pulling numbers out of a hat): the treatment group and the control group. The
treatment group will instructed to take a daily supplement of 1000 mg calcium with 400 mg of
vitamin D. The control group will be given a placebo. Both groups will meet with the
dietitian who will explain the general schedule of study measurements, and instruct them on
how to maintain food records. Patients will be asked to record their dietary intake 3 days
during each 6 month interval (4 times during the study). The dietitian will call patients
to reinforce compliance and answer questions. Every 6 months, the dietitian will review
their intake and conduct questionnaires on food frequency and physical activity. All
patients will receive measures as described above every 6 months for two years, with the
exception of blood work, which will only be done at their planned surgical visit
(approximately 1 /year in this population). Measures for bone mineral density, body
composition, and blood indices as mentioned above will be compared between the two groups.
Upon enrollment, healthy children will have their bone mineral content, bone mineral
density, lean body mass, fat mass and total body water measured. Children will return at 1
and 2 years for a repeat measurement (a total of 3 measures). Data on these measures will be
used for comparison to that obtained in the burned children. These children will also be
asked to record their food intake every 6 month. Food frequency and physical activity will
also be assessed by interview at their 1 year visit.
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