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.