Status:
COMPLETED
CoQ10 Biomarker Trial
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Oxidative Stress
Inflammation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health. In this study, the investigators hypothesize that administra...
Detailed Description
There are more than 400,000 patients receiving dialysis in the United States, and the investigators expect that this number will go up. For those on hemodialysis, cardiovascular disease (CVD) accounts...
Eligibility Criteria
Inclusion
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age ≥ 18 or ≤ 85 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
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 \> 150 mg/day or other antioxidant or nutritional supplements
- Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
- Patients hospitalized for more than 5 days within the past 30 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
- Pregnancy
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01408680
Start Date
November 1 2011
End Date
December 1 2013
Last Update
December 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwest Kidney Centers
Seattle, Washington, United States, 98122