Evidence map›Paper›PMID 24371300›Full record

Trial reportJournal of the American Society of Nephrology : JASN2014

Provision of antioxidant therapy in hemodialysis (PATH): a randomized clinical trial.

Jonathan Himmelfarb, T Alp Ikizler, Charles Ellis, Pingsheng Wu, Ayumi Shintani, Sanjay Dalal, Mark Kaplan, Michel Chonchol, Raymond M Hakim

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00237718 (Provision of Antioxidant Therapy in Hemodialysis), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
5.6field-weighted citation impact, top 3% 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.

NCT00237718 phase2completednot on this map

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

TypeinterventionalSponsorVanderbilt UniversityRan2006 to 2010Enrolled385ConditionsEnd-stage Renal DiseaseArmsAlpha, gamma, beta, and delta (mixed) tocopherols, Alpha lipoic acid, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Antioxidants for adults with chronic kidney disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Systemic Redox Imbalance in Chronic Kidney Disease: A Systematic Review.Oxidative medicine and cellular longevity · 2016
    Pooled it
  5. Trial
  6. Trial
  7. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation · 2015
    Trial
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
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  15. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Jonathan HimmelfarbDepartment of Medicine, Division of Nephrology, University of Washington, Seattle, Washington;
T Alp Ikizler
Charles Ellis
Pingsheng Wu
Ayumi Shintani
Sanjay Dalal
Mark Kaplan
Michel Chonchol
Raymond M Hakim
Vanderbilt University Medical Center · USUniversity of Colorado Denver · USUniversity of Washington · USWestern Michigan University · US

Funding

VANDERBILT UNIVERSITY CTSA FOR PEDIATRIC RESEARCHUL1RR024975 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$45.7M
Structural Biology Facility CoreP30ES000267 · NIEHS · VANDERBILT UNIVERSITY · PI GUENGERICH, F PETER · 1985 to 2014
$20.3M
Oxidative Stress in Chronic Kidney DiseaseR01HL070938 · NHLBI · UNIVERSITY OF WASHINGTON · PI HIMMELFARB, JONATHAN, IKIZLER, TALAT ALP · 2003 to 2012
$3.2M
Nutrition and Metabolism in Dialysis PatientsK24DK062849 · NIDDK · VANDERBILT UNIVERSITY · PI IKIZLER, TALAT ALP · 2003 to 2012
$1.6M
NCRR NIH HHS 1UL-1RR024975NCRR NIH HHS UL1 RR024975NHLBI NIH HHS R01 HL070938NIDDK NIH HHS K24 DK062849NIDDK NIH HHS K24 DK 62849NIEHS NIH HHS P30 ES000267
6 · The paper itself

Abstract

Increased markers of oxidative stress and acute-phase inflammation are prevalent in patients undergoing maintenance hemodialysis therapy (MHD), and are associated with increased mortality and hospitalization rates and decreased erythropoietin responsiveness. No adequately powered studies have examined the efficacy of antioxidant therapies on markers of inflammation and oxidative stress. We tested the hypothesis that oral antioxidant therapy over 6 months would decrease selected biomarkers of acute-phase inflammation and oxidative stress and improve erythropoietic response in prevalent MHD patients. In total, 353 patients were enrolled in a prospective, placebo-controlled, double-blind clinical trial and randomly assigned to receive a combination of mixed tocopherols (666 IU/d) plus α-lipoic acid (ALA; 600 mg/d) or matching placebos for 6 months (NCT00237718); 238 patients completed the study. High-sensitivity C-reactive protein (hsCRP) and IL-6 concentration were measured as biomarkers of systemic inflammation, and F2 isoprostanes and isofurans were measured as biomarkers of oxidative stress. The groups did not significantly differ at baseline. At 3 and 6 months, the treatment had no significant effect on plasma hsCRP, IL-6, F2 isoprostane, or isofuran concentrations and did not improve the erythropoietic response. No major adverse events were related to the study drug, and both groups had similar mortality and hospitalization rates during the study. In conclusion, the administration of mixed tocopherols and ALA was generally safe and well tolerated, but did not influence biomarkers of inflammation and oxidative stress or the erythropoietic response.

Indexed as

AgedAntioxidantsBiomarkersErythropoiesisF2-IsoprostanesFemaleHumansInflammationKidney Failure, ChronicMaleMiddle AgedOxidative StressTocopherolsAntioxidantsBiomarkersF2-IsoprostanesTocopherols

Identifiers

PMID24371300
PMCPMC3935590
OpenAlexW2110303343

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.