Evidence map›Paper›PMID 28278717›Full record

Trial reportLeukemia & lymphoma2017

A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

Etan Orgel, Nicole M Mueske, Richard Sposto, Vicente Gilsanz, Tishya A L Wren, David R Freyer, Anna M Butturini, Steven D Mittelman

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia & lymphoma, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Etan Orgela Children's Center for Cancer and Blood Diseases , Children's Hospital Los Angeles , Los Angeles , CA , USA.ORCID http://orcid.org/0000-0002-1487-6818
Nicole M Mueskec Children's Orthopaedic Center , Children's Hospital Los Angeles , Los Angeles , CA , USA.ORCID http://orcid.org/0000-0003-4459-8289
Richard Spostoa Children's Center for Cancer and Blood Diseases , Children's Hospital Los Angeles , Los Angeles , CA , USA.
Vicente Gilsanzb Keck School of Medicine , University of Southern California , Los Angeles , CA , USA.
Tishya A L Wrenb Keck School of Medicine , University of Southern California , Los Angeles , CA , USA.
David R Freyera Children's Center for Cancer and Blood Diseases , Children's Hospital Los Angeles , Los Angeles , CA , USA.
Anna M Butturinia Children's Center for Cancer and Blood Diseases , Children's Hospital Los Angeles , Los Angeles , CA , USA.
Steven D Mittelmanb Keck School of Medicine , University of Southern California , Los Angeles , CA , USA.
University of Southern California · USChildren's Hospital of Los Angeles · US

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
Southern California Clinical and Translational Science InstituteUL1TR000130 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BUCHANAN, THOMAS A · 2012 to 2015
$36.0M
NCATS NIH HHS UL1 TR000130NCATS NIH HHS UL1 TR001855
6 · The paper itself

Abstract

Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

Indexed as

Bone DensityBone Density Conservation AgentsCholecalciferolPrecursor Cell Lymphoblastic Leukemia-LymphomaAdolescentHumansVitamin D DeficiencyBone Density Conservation AgentsCholecalciferolAcute lymphoblastic leukemiaadolescent and young adultbone mineral densitymedication adherenceosteopeniaVitamin D

Identifiers

PMID28278717
PMCPMC5489365
OpenAlexW2591444522

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.