Evidence map›Paper›PMID 31085814›Full record

ArticleAntiviral therapy2019

Vitamin D does not modulate immune-mediated bone loss during ART initiation.

Michael T Yin, Ellen S Chan, Todd T Brown, Jennifer Kinslow, Jeffrey Martinson, Alan Landay, Kathleen M Melbourne, Heather J Ribaudo, Edgar T Overton, A5280 Study Team

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Antiviral therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01403051 (A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 23% 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.

NCT01403051 phase2completednot on this map

A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2011 to 2013Enrolled167ConditionsHIV-1 InfectionArmsEFV/FTC/TDF, Calcium Carbonate, Vitamin D3, Placebo for calcium carbonate, Placebo for vitamin D3
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
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

10 authors at 5 institutions in 1 country.

Michael T YinDepartment of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Ellen S ChanDepartment of Biostatistics, Harvard Chan School of Public Health, Boston, MA, USA.
Todd T BrownDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jennifer KinslowDepartment of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.
Jeffrey MartinsonDepartment of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.
Alan LandayDepartment of Microbial Pathogens and Immunity, Rush Medical College, Chicago IL, USA.
Kathleen M MelbourneGilead Sciences, Foster City, CA, USA.
Heather J RibaudoDepartment of Biostatistics, Harvard Chan School of Public Health, Boston, MA, USA.
Edgar T OvertonDepartment of Medicine, University of Alabama, Birmingham, AL, USA.
A5280 Study Team
Harvard University · USColumbia University Irving Medical Center · USGilead Sciences (United States) · USJohns Hopkins University · USUniversity of Alabama at Birmingham · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Paul A. Goepfert · 2012 to 2026
$28.8M
HIV and the menopausal transition: effects on musculoskeletal healthR01AI095089 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI YIN, MICHAEL T · 2011 to 2015
$3.3M
NCATS NIH HHS UL1 TR001102NCATS NIH HHS UL1 TR002548NIAID NIH HHS R01 AI095089NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundVitamin D (VitD) and calcium (Ca) supplementation attenuates antiretroviral therapy (ART)-associated bone loss, but it is unclear whether this effect is mediated through immunomodulation.

methodsIn this exploratory analysis of A5280, a 48-week, randomized, double-blind, placebo-controlled study of VitD/Ca supplementation with ART initiation, we characterized lymphocyte phenotypes and receptor activator of nuclear factor kappa-B ligand (RANKL) expression by median fluorescence intensity (MFI) at baseline and 48 weeks. Changes were evaluated within and between treatment groups by Wilcoxon signed rank and rank sum tests, respectively. Spearman correlations estimated relationships between cellular phenotypes and bone mineral density (BMD).

resultsOf 165 participants enrolled, 138 had samples for cellular phenotypes (64 VitD/Ca, 74 placebo). Markers of CD4, CD8 activation (CD38

conclusionsReductions in T-cell activation are characteristic of ART initiation, but only correlated modestly with bone loss. VitD/Ca supplementation does not appear to mitigate bone loss through modulation of immune activation or expression of RANKL. TRIAL REGISTRATION NUMBER: NCT01403051.

Indexed as

ImmunomodulationAdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBiomarkersBone ResorptionCD4 Lymphocyte CountFemaleHIV InfectionsHumansImmunophenotypingMaleMiddle AgedTime FactorsTreatment OutcomeVitamin DAnti-HIV AgentsBiomarkersVitamin D

Identifiers

PMID31085814
PMCPMC6854279
OpenAlexW2946167487

What OpenQuestion holds

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Registered trials

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.