Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Obesity

Vitamin D Deficiency

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Anticoagulants

Gastrointestinal Agents

Vasoconstrictor Agents

Other Dietary Supplements

Vitamins

Vitamin D

Cholecalciferol

Calcium

Citric Acid

Sodium Citrate

Calcium Carbonate

Calcium, Dietary

Calcitriol

Dihydroxycholecalciferols

Trace Elements

Hormones

Antacids

Anti-Ulcer Agents

Citrate

Vitamin D3

Calciferol

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

Vitamin D and Calcium Citrate

Etan Orgel, MD

Steven Mittelman, MD, PhD

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.

Nutrition and Body Composition in Acute Lymphoblastic Leukemia

Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)

Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)

Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)

Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation

Bone mineral density (vBMD) at end of study period (Group B: after 6 months)

Insufficiency defined as 25(OH)D \< 30 ng/ml

The Leukemia and Lymphoma Society

Children's Hospital Los Angeles

Clinical Fellow

Note that subjects in the On-Therapy "natural history" arm (i.e. Group A, not randomized) were not formally followed for adverse event reporting.

Subjects in Sibling group (Arm C) had a single visit for a laboratory draw with no adverse event reporting indicated.

Subjects randomized following Induction to receive education plus:

Vitamin D and Calcium Citrate: 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 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)

On Therapy Intervention (Group A)

Subjects randomized following Induction to receive standard of care with education alone

On Therapy Standard of Care (Group A)

Survivors randomized to receive directly-observed therapy with open-label Vitamin and chewable calcium

Survivorship Intervention (Group B)

Survivors randomized to receive standard of care with education alone OR ineligible for open-label Vitamin D+Calcium randomization

Survivorship Standard of Care (Group B)

Singling of Group A were enrolled for a one-time visit for labs; All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Siblings of Group A (Group C)

Subjects randomized following Induction to receive education plus:

Vitamin D and Calcium Citrate: 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 through study period (total treatment period approximately 6-7 months)P

Subjects surviving to end of Induction but ineligible for randomization for any reason

On Therapy "Natural History" (Group A)

Survivors to receive education plus:

Vitamin D and Calcium Citrate: 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 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)

Survivors either randomized to received standard of care with education alone OR vitamin D sufficient and continued for follow-up only.

Siblings (Group C)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Dr. Etan Orgel

Change in serum Vitamin 25(OH)D level

Post-intervention serum Vitamin 25(OH)D level

On-Therapy Intervention (Group A)

Subjects randomized following Induction to receive standard of care with education alone OR subjects ineligible for open-label randomization and followed as "natural history" cohort.

Patients enrolled prior to open-label randomization and those not eligible for randomization at end of induction

On-Therapy "Natural History" (Group A)

Includes subjects in each group evaluable for vitamin D endpoint. Calculation of change = Vitamin D level at study end (end of DI, \~+6 months)/Vitamin D level at baseline (start of consolidation).

Change in Serum Vitamin D Level (Group A)

Cortical BMD

Cancellous BMD

On-Therapy "Natural History" (Group A, Tibia)

Subjects enrolled following the change to the open-label randomization were imaged for cortical bone density at the femur, subjects enrolled prior to this in the Natural History group were imaged at the tibia. The change was made for later subjects due to technical reasons to provide a better estimate of cortical density.

Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)

Subjects randomized to receive education plus directly-observed therapy with open-label Vitamin D and chewable calcium

Survivors randomized to receive standard of care with education alone OR subjects ineligible for open-label Vitamin D+ Calcium randomization and continued with follow-up only.

Change in Vitamin D = Vitamin D at +6months/Vitamin D at baseline

Change in Vitamin D Level (Group B)

Cortical bone mineral density

Cancellous bone mineral density

Bone Mineral Density by QCT in Survivors at Study End (Group B)

Healthy siblings of survivors of pediatric ALL for one-time assessment

Siblings of Survivors (Group C)

Newly Diagnosed Patients (Group A)

Group C: Only four siblings enrolled and arm closed early due to poor accrual. Specimens from this group were not analyzed so no results are available.

Group A: 39 subjects enrolled at diagnosis had Vitamin D testing performed at diagnosis and had results available.

Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings

Healthy siblings of survivors of pediatric acute lymphoblastic leukemia (ALL) for one-time assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nutrition and Body Composition in Acute Lymphoblastic Leukemia	NCT01317940	Precursor Cell ... Vitamin D Defic...	Vitamin D and C...	10 Years - 29 Years	Children's Hospital Los Angeles
Nutrition and Body Composition in Acute Lymphoblastic Leukemia	NCT01317940	Precursor Cell ... Vitamin D Defic...	Vitamin D and C...	10 Years - 29 Years	Children's Hospital Los Angeles

Spots Global Cancer Trial Database for vitamin d and calcium citrate