Evidence map›Paper›PMID 35834528›Full record

Trial reportPloS one2022

A randomized control trial of high-dose micronutrient-antioxidant supplementation in healthy persons with untreated HIV infection.

Wendy L Wobeser, Joanne E McBane, Louise Balfour, Brian Conway, M John Gill, Harold Huff, Donald L P Kilby, Dean A Fergusson, Ranjeeta Mallick, Edward J Mills and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00798772 (A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection), 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
0.3field-weighted citation impact, top 44% 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.

NCT00798772 nacompletednot on this map

A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2009 to 2017Enrolled171ConditionsHIV InfectionArmsMicronutrients and antioxidants, Multivitamins and minerals
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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

22 authors at 12 institutions in 2 countries.

Wendy L WobeserDepartment of Biomedical and Molecular Sciences and Public Health, Queen's University, Kingston, Ontario, Canada.ORCID 0000-0002-9490-9877
Joanne E McBaneCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Louise BalfourCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Brian ConwayVancouver Infectious Disease Clinic, Vancouver, British Columbia, Canada.
M John GillCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Harold HuffCanadian College of Naturopathic Medicine, Toronto, Ontario, Canada.
Donald L P KilbyFaculty of Health Services, University of Ottawa, Ottawa, Ontario, Canada.
Dean A FergussonClinical Epidemiology Program (CEP), University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
Ranjeeta MallickOttawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Edward J MillsCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Katherine A MuldoonOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Anita RachlisCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Edward D RalphDivision of Infectious Diseases, Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Ron RosenesCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.ORCID 0000-0001-6263-0428
Joel SingerCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
Neera SinghalGlobal Evaluative Sciences, Vancouver, British Columbia, Canada.
Darrell TanCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.ORCID 0000-0002-3069-2875
Nancy TremblayOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dong VoOttawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Sharon L WalmsleyCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.
D William CameronCIHR Canadian HIV Trials Network (CIHR-CTN), Vancouver, British Columbia, Canada.ORCID 0000-0002-0090-3539
MAINTAIN Study Group
University of Ottawa · CAOttawa Hospital · CAInstitute for Clinical Evaluative Sciences · CAUniversity of Toronto · CACanadian College of Naturopathic Medicine · CAHIV Legal Network · CAQueen's University · CASt. Michael's Hospital · CAUniversity of British Columbia · CAUniversity of Calgary · CAVancouver Infectious Diseases Centre · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough micronutrient and antioxidant supplementation are widely used by persons with human immunodeficiency virus (HIV), a therapeutic role beyond recommended daily allowances (RDA) remains unproven. An oral high-dose micronutrient and antioxidant supplement (Treatment) was compared to an RDA supplement (Control) for time to progressive immunodeficiency or initiation of antiretroviral therapy (ART) in people living with HIV (PLWH).

methodsThis study was a randomized, double-blind, placebo-controlled multicenter clinical trial. PLWH were recruited from Canadian HIV Trials Network sites, and followed quarterly for two years. Eligible participants were asymptomatic, antiretroviral treatment (ART)-naïve, HIV-seropositive adults with a CD4 T lymphocyte count (CD4 count) between 375-750 cells/μL. Participants were randomly allocated 1:1 to receive Treatment or Control supplements. The primary outcome was a composite of time-to-first of confirmed CD4 count below 350 cells/μL, initiation of ART, AIDS-defining illness or death. Primary analysis was by intention-to-treat. Secondary outcomes included CD4 count trajectory from baseline to ART initiation or two years. A Data and Safety Monitoring Board reviewed the study for safety, recruitment and protocol adherence every six months.

resultsOf 171 enrolled participants: 66 (38.6%) experienced a primary outcome: 27 reached a CD4 count below 350 cells/μL, and 57 started ART. There was no significant difference in time-to-first outcome between groups (Hazard Ratio = 1.05; 95%CI: 0.65, 1.70), or in time to any component outcome. Using intent-to-treat censoring, mean annualized rates of CD4 count decline were -42.703 cells/μL and -79.763 cells/μL for Treatment and Control groups, with no statistical difference in the mean change between groups (-37.06 cells/μL/52 weeks, 95%CI: (-93.59, 19.47); p = 0.1993). Accrual was stopped at 171 of the 212 intended participants after an interim analysis for futility, although participant follow-up was completed.

conclusionsIn ART-naïve PLWH, high-dose antioxidant, micronutrient supplementation compared to RDA supplementation had no significant effect on disease progression or ART initiation. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT00798772.

Indexed as

HIV InfectionsAdultAntioxidantsCanadaCD4 Lymphocyte CountDietary SupplementsHumansMicronutrientsTreatment OutcomeViral LoadAntioxidantsMicronutrients

Identifiers

PMID35834528
PMCPMC9282469
OpenAlexW4285387843

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.