Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Fresenius Medical Care North America
• Treatments: alpha-Tocopherol; Antioxidants; Thioctic Acid; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

1. Patients with end-stage renal disease receiving thrice weekly hemodialysis

2. Age > 18 years

3. Life expectancy greater than one year

4. Ability to understand and provide informed consent for participation in the study

Exclusion Criteria:

1. AIDS (HIV seropositivity is not an exclusion criteria)

2. Active malignancy excluding basal cell carcinoma of the skin

3. Gastrointestinal dysfunction requiring parenteral nutrition

4. History of functional kidney transplant < 6 months prior to study entry

5. Anticipated live donor kidney transplant over study duration

6. History of poor adherence to hemodialysis or medical regimen

7. Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations

8. Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the past 30 days

9. Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days

10. Patients using a temporary catheter for dialysis access

11. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days