Nutrition and Body Composition in Acute Lymphoblastic Leukemia

June 19, 2020 updated by: Etan Orgel, Children's Hospital Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Calcitriol
  • 1,25-Dihydroxycholecalciferol
  • Calcium carbonate
  • Rocaltrol (Roche)
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:
  • Calcitriol
  • 1,25-Dihydroxycholecalciferol
  • Calcium carbonate
  • Rocaltrol (Roche)
No Intervention: Observation Only - Group B
No Intervention: Group C (Siblings of Group A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
+6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
+6 months
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
+6 months
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)
+6 months
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
1 timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Collaborators

The Leukemia and Lymphoma Society

Investigators

  • Principal Investigator: Steven Mittelman, MD, PhD, Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (Estimate)

March 18, 2011

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCI-10-00273
  • LLS 6249-11 (Other Grant/Funding Number: Leukemia and Lymphoma Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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