Nutrition and Body Composition in Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified March 2014 by Children's Hospital Los Angeles
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Etan Orgel, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01317940
First received: March 17, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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 a quantitative computed tomography (or "qCT") while body composition and body fat will be measured by a different radiology exam called a dual energy x-ray absorptiometry (or "DEXA" 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.


Condition Intervention Phase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Vitamin D Deficiency
Dietary Supplement: Vitamin D and Calcium Citrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Repletion of serum Vitamin D Status [ Time Frame: 6 - 8 months ] [ Designated as safety issue: No ]
    Repletion of serum Vitamin D levels (to greater than 30 ng/ml) will be measured at the end of Delayed Intensification #1 phase in the group of newly diagnosed patients and at the end of a 6 month period in the early survivor group.


Secondary Outcome Measures:
  • To describe the relationship between Vitamin D, adipose tissue, and bone density in patients with ALL undergoing induction and post-remission therapy and in early survivors [ Time Frame: 6 - 8 months ] [ Designated as safety issue: No ]
  • To measure the effect of Vitamin D supplementation on changes in bone density [ Time Frame: 6 - 8 months ] [ Designated as safety issue: No ]
    The study will examine the efficacy of Vitamin D and calcium supplementation in maintaining or improving bone density in Vitamin D insufficient adolescents on therapy for ALL and in early survivors

  • To compare the prevalence of obesity and Vitamin D deficiency in adolescents with newly diagnosed ALL and in their siblings [ Time Frame: 1 timepoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: March 2011
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A (Newly Diagnosed Subjects) Dietary Supplement: 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 for approximately 6-7 months

Other Names:
  • 1,25-Dihydroxycholecalciferol
  • Calcitriol
  • Rocaltrol (Roche)
  • TUMS
  • Calcium carbonate
No Intervention: Standard of Care Group A
Experimental: Group B (Early Survivors) Dietary Supplement: 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 for approximately 6-7 months

Other Names:
  • 1,25-Dihydroxycholecalciferol
  • Calcitriol
  • Rocaltrol (Roche)
  • TUMS
  • Calcium carbonate
No Intervention: Observation Only - Group B
No Intervention: Group C (Siblings of Group A)

  Eligibility

Ages Eligible for Study:   10 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 complete remission ("CR1")
  • 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 400IU/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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317940

Contacts
Contact: Etan Orgel, MD, MS 323-361-2121 eorgel@chla.usc.edu
Contact: Steven Mittelman, MD, PhD 323-361-7653 smittelman@chla.usc.edu

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Etan Orgel, MD    323-361-2984    eorgel@chla.usc.edu   
Contact: Steven Mittelman, MD    323-361-7653    smittelman@chla.usc.edu   
Principal Investigator: Etan Orgel, MD         
Principal Investigator: Steven Mittelman, MD, PhD         
Sponsors and Collaborators
Children's Hospital Los Angeles
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Etan Orgel, MD Children's Hospital Los Angeles
Principal Investigator: Steven Mittelman, MD, PhD Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Etan Orgel, Clinical Fellow, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01317940     History of Changes
Other Study ID Numbers: CCI-10-00273, LLS 6249-11
Study First Received: March 17, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Los Angeles:
Leukemia
ALL
Vitamin D
Bone Density
Body Fat
Obesity
Adipose

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Vitamin D Deficiency
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcitriol
Dihydroxycholecalciferols
Vitamin D
Ergocalciferols
Vitamins
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014