Abstract
OBJECTIVE: Although increased oxidative stress and inflammation are highly prevalent in chronic kidney disease (CKD), few studies have investigated whether oral antioxidant therapy can alter markers of inflammation or oxidative stress in patients with CKD. The purpose of this study was to investigate whether a combination of mixed tocopherols and alpha lipoic acid (ALA) would alter biomarkers of oxidative stress and inflammation in subjects with stage 3 to 4 CKD. METHODS: This was a prospective, randomized, double-blind, placebo-controlled pilot trial. In all, 62 subjects were enrolled and were randomly assigned to receive a combination of mixed tocopherols 666 IU/day, in addition to ALA 600 mg/day, or their matching placebos for a total of 8 weeks. Plasma F(2)-isoprostane and protein thiol concentration were measured as biomarkers of oxidative stress, and C-reactive protein and interleukin-6 concentration as biomarkers of systemic inflammation. RESULTS: There were no significant differences in demographics, diabetic status, or estimated glomerular filtration rate between study treatment and placebo groups at baseline. Of the 62 randomized subjects, 58 (93%) completed the study protocol. After 2 months of treatment, there were no significant changes in the concentrations of F(2)-isoprostanes, protein thiols, C-reactive protein, and interleukin-6 with respect to treatment with mixed tocopherols and ALA as compared with matching placebos, whether analyzed as intention to treat or as treated. Diabetic status and baseline body mass index did not influence the results. CONCLUSIONS: Combination of oral mixed tocopherols and ALA treatment for 2 months does not influence biomarkers of oxidative stress and inflammation in patients with stage 3 to 4 CKD.