Evidence map›Paper›PMID 29255724›Full record

ArticleOpen forum infectious diseases2017

Vitamin D Supplementation Does Not Affect Metabolic Changes Seen With ART Initiation.

Josh Muhammad, Ellen S Chan, Todd T Brown, Pablo Tebas, Grace A McComsey, Kathleen Melbourne, Royce Hardin, Amanda L Willig, Michael T Yin, Heather Ribaudo and 1 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
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

11 authors at 8 institutions in 1 country.

Josh MuhammadDepartment of Nutrition Sciences, University of Alabama-Birmingham.
Ellen S ChanCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
Todd T BrownDivision of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University.
Pablo TebasDepartment of Medicine, Hospital of the University of Pennsylvanian.
Grace A McComseyDepartment of Pediatrics, Case Western Reserve University and University Hospitals Cleveland Medical Center.
Kathleen MelbourneGilead Sciences.
Royce HardinCommunity Advisory Board, Chapel Hill Clinical Research Site of the AIDS Clinical Trials Group.
Amanda L WilligDivision of Infectious Diseases, University of Alabama-Birmingham.
Michael T YinDivision of Infectious Diseases, Columbia University.
Heather RibaudoCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health.
Edgar Turner OvertonDivision of Infectious Diseases, University of Alabama-Birmingham.
University of Alabama at Birmingham · USCancer Research And Biostatistics · USAIDS Clinical Trials Group · USCase Western Reserve University · USColumbia University · USGilead Sciences (United States) · USHospital of the University of Pennsylvania · USJohns Hopkins University · 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
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
Clinical and Translational Science Collaborative of Northern Ohio, Catalyzing Linkages to Equity in Health (CLE Health)UM1TR004528 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI GRACE A MCCOMSEY · 2023 to 2026
$32.1M
NCATS NIH HHS UM1 TR004528NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundInsulin resistance and lipid changes are common after antiretroviral therapy (ART) initiation. Observational studies suggest that vitamin D supplementation reduces the risk of developing diabetes and improves lipid profiles.

methodsThis 48-week prospective, randomized, double-blind, placebo-controlled study evaluated high-dose vitamin D3 (4000 IU daily) plus calcium supplementation (1000 mg calcium carbonate daily) in HIV-infected participants initiating ART with efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). Changes in insulin resistance (as estimated by homeostatic model assessment), fasting lipid profile, and components of the metabolic syndrome were assessed at baseline, 24 weeks, and 48 weeks. Stratified Wilcoxon rank sum tests and stratified normal score tests were used to evaluate differences between treatment arms, stratified by screening 25-OH vitamin D stratum (≤/>20 ng/mL).

resultsA total of 165 participants enrolled: 79 in the vitamin D/calcium (Vit D/Cal) arm and 86 in the placebo arm. Only the placebo arm experienced a modest increase in insulin resistance at week 24 (

conclusionsVit D/Cal supplementation over 48 weeks did not alter the lipid profile or glucose metabolism experienced with initiation of EFV/FTC/TDF in ART-naïve persons. Vitamin D supplementation is unlikely to be an effective strategy to attenuate metabolic dysregulations with ART initiation.

Identifiers

PMID29255724
PMCPMC5726464
OpenAlexW2773646564

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.