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Precursor Cell Lymphoblastic Leukemia-LymphomaPhase 2NCT01317940

Nutrition and Body Composition in Acute Lymphoblastic Leukemia

A Phase 2 study testing Vitamin D and Calcium Citrate in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma and Vitamin D Deficiency, run by Children's Hospital Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 29 yearsHealthy volunteers can take part
What is being tested?
Vitamin D and Calcium Citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
Mar 2011to Jan 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

Other trials in United States

About this study

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

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.

Being tested
Vitamin D and Calcium Citrate
Keywords
Leukemia, ALL, Vitamin D, Bone Density, Body Fat, Obesity, Adipose
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vitamin D Deficiency, Leukemia, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D and Calcium CitrateDietary supplement

    Also called 1,25-Dihydroxycholecalciferol, Calcitriol, Rocaltrol (Roche), Calcium carbonate

    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

Study groups in NCT01317940
Study groupRoleWhat they receive
Group A (Newly Diagnosed Subjects)ExperimentalNot described
Receives: Dietary Supplement: Vitamin D and Calcium Citrate
Standard of Care Group ANo interventionNot described
Group B (Early Survivors)ExperimentalNot described
Receives: Dietary Supplement: Vitamin D and Calcium Citrate
Observation Only - Group BNo interventionNot described
Group C (Siblings of Group A)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: +6 months

Secondary outcomes (4)

  1. 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)

    Measured: +6 months

  2. 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

    Measured: +6 months

  3. 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)

    Measured: +6 months

  4. 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

    Measured: 1 timepoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2014
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01317940
Sponsor's protocol ID
CCI-10-00273
Other IDs
LLS 6249-11
Status last verified
Jun 2020
First submitted
17 Mar 2011
Last updated
8 Jul 2020
Data monitoring committee
Yes

Publications

  • Orgel E, Framson C, Buxton R, Kim J, Li G, Tucci J, Freyer DR, Sun W, Oberley MJ, Dieli-Conwright C, Mittelman SD. Caloric and nutrient restriction to augment chemotherapy efficacy for acute lymphoblastic leukemia: the IDEAL trial. Blood Adv. 2021 Apr 13;5(7):1853-1861. doi: 10.1182/bloodadvances.2020004018.

    PubMed 33792627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D and Calcium Citrate in people with Precursor Cell Lymphoblastic Leukemia-Lymphoma and Vitamin D Deficiency, run by Children's Hospital Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Vitamin D Level (Group A) (time frame: +6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01317940, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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