Back to resultsNutrition and Body Composition in Acute Lymphoblastic Leukemia
Primary Purpose
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vitamin D Deficiency
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D and Calcium Citrate
Sponsored by
About this trial
This is an interventional supportive care trial for Precursor Cell Lymphoblastic Leukemia-Lymphoma focused on measuring Leukemia, ALL, Vitamin D, Bone Density, Body Fat, Obesity, Adipose
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)
Sites / Locations
- Children's Hospital Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
No Intervention
Experimental
No Intervention
No Intervention
Arm Label
Group A (Newly Diagnosed Subjects)
Standard of Care Group A
Group B (Early Survivors)
Observation Only - Group B
Group C (Siblings of Group A)
Arm Description
Outcomes
Primary Outcome Measures
Change in Serum Vitamin D Level (Group A)
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
Secondary Outcome Measures
Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)
Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)
Change in Vitamin D Level (Group B)
Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation
Bone Mineral Density by QCT in Survivors at Study End (Group B)
Bone mineral density (vBMD) at end of study period (Group B: after 6 months)
Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings
Insufficiency defined as 25(OH)D < 30 ng/ml
Full Information
NCT ID
NCT01317940
First Posted
March 17, 2011
Last Updated
June 19, 2020
Sponsor
Children's Hospital Los Angeles
Collaborators
The Leukemia and Lymphoma Society
1. Study Identification
Unique Protocol Identification Number
NCT01317940
Brief Title
Nutrition and Body Composition in Acute Lymphoblastic Leukemia
Official Title
Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
The Leukemia and Lymphoma Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vitamin D Deficiency
Keywords
Leukemia, ALL, Vitamin D, Bone Density, Body Fat, Obesity, Adipose
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Newly Diagnosed Subjects)
Arm Type
Experimental
Arm Title
Standard of Care Group A
Arm Type
No Intervention
Arm Title
Group B (Early Survivors)
Arm Type
Experimental
Arm Title
Observation Only - Group B
Arm Type
No Intervention
Arm Title
Group C (Siblings of Group A)
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D and Calcium Citrate
Other Intervention Name(s)
1,25-Dihydroxycholecalciferol, Calcitriol, Rocaltrol (Roche), Calcium carbonate
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
Primary Outcome Measure Information:
Title
Change in Serum Vitamin D Level (Group A)
Description
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
Time Frame
+6 months
Secondary Outcome Measure Information:
Title
Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)
Description
Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)
Time Frame
+6 months
Title
Change in Vitamin D Level (Group B)
Description
Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation
Time Frame
+6 months
Title
Bone Mineral Density by QCT in Survivors at Study End (Group B)
Description
Bone mineral density (vBMD) at end of study period (Group B: after 6 months)
Time Frame
+6 months
Title
Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings
Description
Insufficiency defined as 25(OH)D < 30 ng/ml
Time Frame
1 timepoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etan Orgel, MD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Mittelman, MD, PhD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33792627
Citation
Orgel E, Framson C, Buxton R, Kim J, Li G, Tucci J, Freyer DR, Sun W, Oberley MJ, Dieli-Conwright C, Mittelman SD. Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Blood Adv. 2021 Apr 13;5(7):1853-1861. doi: 10.1182/bloodadvances.2020004018.
Results Reference
derived
Links:
URL
http://ods.od.nih.gov/factsheets/vitamind/
Description
NIH Vitamin D Fact Sheet
Learn more about this trial
Nutrition and Body Composition in Acute Lymphoblastic Leukemia
We'll reach out to this number within 24 hrs