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| Sponsors and Collaborators: |
National Institute of Environmental Health Sciences (NIEHS) Leonard B Rosenberg Renal Research Foundation |
| Information provided by: | National Institute of Environmental Health Sciences (NIEHS) |
| ClinicalTrials.gov Identifier: | NCT00410449 |
Purpose
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.
| Condition | Intervention | Phase |
|
End Stage Renal Disease Hemodialysis |
Drug: Alpha tocopherol |
Phase IV |
| MedlinePlus related topics: | Dialysis Kidney Failure Stress |
| ChemIDplus related topics: | Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | 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 |
| Estimated Enrollment: | 35 |
| Study Start Date: | May 2001 |
| Estimated Study Completion Date: | May 2004 |
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.
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)
Exclusion Criteria:
Temporary catheter dialysis access, inability to be compliant with study medication
Contacts and Locations| United States, Ohio | |||||
| Center for Dialysis Care | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| National Institute of Environmental Health Sciences (NIEHS) |
| Leonard B Rosenberg Renal Research Foundation |
| Principal Investigator: | Miriam F Weiss, M.D. | Case Western Reserve University |
More Information
| Study ID Numbers: | 11461-CP-001, NIEHS ES11461 |
| First Received: | December 11, 2006 |
| Last Updated: | December 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00410449 |
| Health Authority: | United States: Federal Government |
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