Nutrition and Body Composition in Acute Lymphoblastic Leukemia
Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vitamin D Deficiency
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Vitamin D Deficiency
Intervention: Vitamin D and Calcium Citrate
Intervention description: 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
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Calcitriol; Dihydroxycholecalciferols; Calcium Carbonate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 10 Years
Maximum age: 29 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Leukemia; ALL; Vitamin D; Bone Density; Body Fat; Obesity; Adipose

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.
    

Eligibility criteria:

        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)