Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue. In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
76
Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months
Children's Hospital Los Angeles
Los Angeles, California, United States
Change in Serum Vitamin D Level (Group A)
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
Time frame: +6 months
Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)
Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)
Time frame: +6 months
Change in Vitamin D Level (Group B)
Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation
Time frame: +6 months
Bone Mineral Density by QCT in Survivors at Study End (Group B)
Bone mineral density (vBMD) at end of study period (Group B: after 6 months)
Time frame: +6 months
Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings
Insufficiency defined as 25(OH)D \< 30 ng/ml
Time frame: 1 timepoint
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