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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: Completed Phase 2 study, sponsored by Children's Hospital Los Angeles.
NCT01317940 is a Phase 2 study that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)
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 |
What the finished NCT01317940 record still lists
NCT01317940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D and Calcium Citrate is the first listed.
NCT01317940 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01317940's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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