Nutrition and Body Composition in Acute Lymphoblastic Leukemia

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317940
• Other study ID #: CCI-10-00273
• Secondary ID: LLS 6249-11
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: January 2016

Study information

• Verified date: June 2020
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	+6 months
Secondary	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)	+6 months
Secondary	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	+6 months
Secondary	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)	+6 months
Secondary	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	1 timepoint

External Links

•   NIH Vitamin D Fact Sheet