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NCT01317940 · ClinicalTrials.gov registry record · Phase 2
Nutrition and Body Composition in Acute Lymphoblastic Leukemia
A Phase 2 study, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT01317940 is a Phase 2 study that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 76 participants.
The verdict
NCT01317940, a Phase 2 study, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Vitamin D and Calcium Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01317940
The ClinicalTrials.gov registry entry for NCT01317940 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin D and Calcium Citrate is the first listed.
NCT01317940 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01317940 about?
NCT01317940 is a clinical study titled "Nutrition and Body Composition in Acute Lymphoblastic Leukemia". 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 Vitami...
What is the current status of trial NCT01317940?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2011-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01317940?
The interventions under investigation include: Vitamin D and Calcium Citrate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01317940?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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