Provision of Antioxidant Therapy in Hemodialysis (PATH): A Randomized Clinical Trial
Open accessAbstract
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.
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In hemodialysis patients, 6 months of alpha-lipoic acid and mixed tocopherols did not improve plasma oxidative stress markers F2 isoprostane, isofuran, and IL-6.
“While treatment was well tolerated it did not improve plasma levels of oxidative stress markers such as F2 isoprostane, isofuran, and IL-6 (Himmelfarb et al. 2014).”
From Reactive Oxygen Species, Toxicity, Oxidative Stress, and Antioxidants: Chronic Diseases and Aging (2023) · cites this paper as Himmelfarb et al. 2014
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- Authors
- Himmelfarb, J., Ikizler, T. A., Ellis, C., Wu, P., Shintani, A., Dalal, S., Kaplan, M., Chonchol, M., & Hakim, R. M.
- Affiliations
- University of Washington (US)
- Vanderbilt University Medical Center (US)
- Western Michigan University (US)
- University of Colorado Denver (US)
- Corresponding author
- Himmelfarb, Jonathan
- ORCID
- Venue
- Journal of the American Society of Nephrology
- Published
- 2014-03
- Volume
- 25
- Issue
- 3
- Pages
- 623-633
- ISSN
- 1046-6673 (ISSN-L)
- PMC
- PMC3935590
- OpenAlex
- W2110303343
- Cited by
- 69
- References
- 58
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 4 · 2022: 5 · 2021: 4 · 2020: 4 · 2019: 5 · 2018: 7 · 2017: 5 · 2016: 14 · 2015: 12 · 2014: 5 · 2013: 1
- FWCI
- 8.08
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of the American Society of Nephrology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL070938)
- National Institute of Diabetes and Digestive and Kidney Diseases (K24-DK62849, K24DK062849)
- National Institute of Environmental Health Sciences (P30ES000267)
- National Center for Research Resources (UL1RR024975)
- Topics
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Health Sciences › Medicine › Biochemistry › Antioxidant Activity and Oxidative Stress
- Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
- Keywords
- antioxidant therapy, maintenance hemodialysis, oxidative stress, acute phase inflammation, tocopherols, alpha-lipoic acid, erythropoietin response, C-reactive protein, interleukin-6, F2-isoprostanes, isofurans, mortality, hospitalization
- MeSH terms
- Aged, Antioxidants, Erythropoiesis, Female, Humans, Inflammation, Kidney Failure, Chronic, Male, Middle Aged, Biomarkers, Oxidative Stress, Tocopherols, F2-Isoprostanes
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