Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

Completed · Not applicable

Conditions studied: Cardiovascular Disease, End Stage Renal Disease, Atherosclerosis, Oxidative Stress

In brief

The purpose of this study is to determine the safety and tolerability of the dietary supplement Coenzyme Q10 in hemodialysis patients.

Key facts

Study ID

NCT00908297

Run by

University of Washington

People needed

20

Starts

2010-02-01

Expected to finish

2010-11-01

Last updated by the study team

2012-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwest Kidney Centers - Scribner — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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