Nutrition and Body Composition in Acute Lymphoblastic Leukemia
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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) |
- 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.
- 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: | March 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:
|
| 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:
|
| 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 |
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| Contact: Etan Orgel, MD, MS | 323-361-2121 | eorgel@chla.usc.edu |
| Contact: Steven Mittelman, MD, PhD | 323-361-7653 | smittelman@chla.usc.edu |
| 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 | |
| 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: | May 23, 2012 |
| 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 May 16, 2013