NCT00410449

Oxidative Stress and Hemodialysis Access Failure

Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (planned)
• Sponsor: National Institute of Environmental Health Sciences (NIEHS) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.

Detailed description

Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.

Conditions

• End Stage Renal Disease
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Alpha tocopherol

Timeline

• Start date: 2001-05-01
• Completion: 2004-05-01
• First posted: 2006-12-12
• Last updated: 2015-10-06

Locations

1 site across 1 country: United States