Status:
COMPLETED
Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Cardiovascular Disease
End Stage Renal Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and tolerability of the dietary supplement Coenzyme Q10 in hemodialysis patients.
Detailed Description
There are more than 400,000 patients receiving dialysis in the United States, and we expect that this number will go up. For those on hemodialysis, cardiovascular disease (CVD) accounts for a large pa...
Eligibility Criteria
Inclusion
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age \> 18 and \< 85 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
- Mean baseline plasma F2-isoprostane concentration \> 50 pg/mL
Exclusion
- History of poor adherence to hemodialysis or medical regimen
- Prisoners, patients with significant mental illness, and other vulnerable populations
- AIDS (HIV seropositivity is not an exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
- History of functional kidney transplant \< 6 months prior to study entry
- Anticipated live donor kidney transplant
- Patients taking vitamin E supplements \> 60 IU/day, vitamin C \> 50 mg/day or other antioxidant or nutritional supplements
- Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
- Patients hospitalized within the past 60 days
- Patients being dialyzed with a tunneled catheter as a temporary vascular access
- Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within six months
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00908297
Start Date
February 1 2010
End Date
November 1 2010
Last Update
April 24 2012
Active Locations (1)
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1
Northwest Kidney Centers - Scribner
Seattle, Washington, United States, 98122