NCT00237718

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Detailed description

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
DRUG	Alpha, gamma, beta, and delta (mixed) tocopherols	approximately 666 IU daily (1 pill) for 6 months
DRUG	Alpha lipoic acid	600 mg daily (2 pills 300 mg each) for 6 months
DRUG	Placebo	placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months
DRUG	Placebo	placebo for alpha lipoic acid; 2 pills daily for 6 months

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2005-10-12
• Last updated: 2012-01-11
• Results posted: 2011-10-05

Locations

1 site across 1 country: United States