Phase 2
N=72
Nutrition and Body Composition in Acute Lymphoblastic Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma · Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01317940 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Change in Serum Vitamin D Level (Group A) — 5.5; -0.30; 1.0; 26.5 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D and Calcium Citrate (Dietary_supplement)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Vitamin D Level (Group A) |
5.5; -0.30; 1.0; 26.5; 19.0; 23.3 | — |
| SECONDARY Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A) |
2093.1; 2090.9; 927.5; 203.8; 201.4; 159.1 | — |
| SECONDARY Change in Vitamin D Level (Group B) |
1.0; -1.0; 26.0; 29.0 | — |
| SECONDARY Bone Mineral Density by QCT in Survivors at Study End (Group B) |
2087.4; 2049.3; 243.6; 269.3 | — |
| SECONDARY Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings |
0; 36 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01317940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.