Vitamin D Deficiency Clinical Trial
Official title:
Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)
Verified date | June 2020 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | The Leukemia and Lymphoma Society |
United States,
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 |
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