Nutrition and Body Composition in Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Vitamin D Deficiency

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

GROUP A: Patients with newly diagnosed ALL

Are greater than or equal to 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
Have a new diagnosis of untreated ALL classified as "high risk" per NCI criteria (due to being greater than 10 years of age)
Are beginning treatment with a Children's Cancer Group/Children's Oncology Group "high risk" protocol with a 4-drug induction including steroids
Are not pregnant

GROUP B: Early survivors of ALL

Were treated for ALL and remain in first CR1 (complete remission)
Were equal to or greater than 10 years of age and less than or equal to 21 years of age at diagnosis of ALL
Have completed treatment on or as per a Children's Cancer Group/Children's Oncology Group "high risk" protocol between 12 and 48 months prior to enrollment in this study (consisting of a plan for a 4-drug induction including steroids in Induction, Delayed Intensification, and steroid pulses in Maintenance. Steroids are allowed to have been discontinued due to toxicity).
Are not pregnant

GROUP C: Siblings of Group A

Are either a full-sibling or a half-sibling of a patient in Group A
Are living at the same residence as the sibling/half-sibling from Group A
Are greater than or equal to 10 years of age and less than or equal to 21 years of age at the time of study entry, and within 3 years of the age diagnosis of ALL in the sibling/half-sibling from Group A
Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group A at the time of his or her diagnosis

Exclusion Criteria (All Groups):

Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with abnormal bone development
Are undergoing treatment with other medicines that affect bones including chronic use of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than 400 international units (IU)/day
Have an underlying diseases altering body structure (i.e. missing a limb, severe dysmorphism) or severely affecting mobility (i.e. total or hemiparesis)
Have a history of chemotherapy or radiation for other cancers
Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with a hip replacement or prosthesis)

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Group B (Early Survivors)	Vitamin D and Calcium Citrate	-
Group A (Newly Diagnosed Subjects)	Vitamin D and Calcium Citrate	-

Primary Outcome Measures

Name	Time	Method
Change in Serum Vitamin D Level (Group A)	+6 months	Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density by QCT in Survivors at Study End (Group B)	+6 months	Bone mineral density (vBMD) at end of study period (Group B: after 6 months)
Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)	+6 months	Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)
Change in Vitamin D Level (Group B)	+6 months	Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation
Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings	1 timepoint	Insufficiency defined as 25(OH)D \< 30 ng/ml