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Completed

NCT Number: NCT01317940

Nutrition and Body Composition in Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma Avitaminosis Body Weight Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Malnutrition Neoplasms Neoplasms by Histologic Type Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

10 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D and Calcium Citrate

Dietary Supplement

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

Other names: 1,25-Dihydroxycholecalciferol, Calcitriol, Rocaltrol (Roche), Calcium carbonate

Primary outcomes

  1. Change in Serum Vitamin D Level (Group A)

    Time frame: +6 months

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

Secondary outcomes

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

    Time frame: +6 months

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

  2. Change in Vitamin D Level (Group B)

    Time frame: +6 months

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

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

    Time frame: +6 months

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

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

    Time frame: 1 timepoint

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Mar 18, 2011
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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