Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00908297

Collaborator

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease End Stage Renal Disease Atherosclerosis Oxidative Stress	Dietary Supplement: Coenzyme Q10	N/A

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 part of the health problems that these patients have. Cardiovascular problems come from damage to the heart or blood vessels.

At present, we have no treatments proven to help prevent CVD in those on dialysis. For the general population, we know about many factors that increase the risk of CVD, such as having a high level of "bad" cholesterol. But for people on dialysis, we believe that there are other risk factors that are just as important in the development of CVD.

People on dialysis often have high blood levels of waste products. This is called "uremia". We believe that uremia can set up chemical reactions in the blood which can lead to hardening of the arteries (atherosclerosis), an important part of CVD. Compounds called antioxidants, which stop the chemical reactions, may help prevent CVD.

Coenzyme Q10 is a naturally occurring compound in blood and tissues. It is also a readily available dietary supplement often used as an alternative and complementary medicine. It is a powerful antioxidant. Previous studies have shown that blood levels of coenzyme Q10 are decreased in hemodialysis patients. Because of this, it is important for us to find out if giving coenzyme Q10 to hemodialysis patients can help prevent CVD. However, at present, there are no studies which carefully look at the safety and tolerability of coenzyme Q10, and whether it helps stops the harmful chemical reactions in the blood.

In addition, many people take medications called "statins" to help reduce risk for cardiovascular disease. We know that statins can lower coenzyme Q10. It is important for us to know if hemodialysis patients taking statins have lower levels of coenzyme Q10. It may be that therapy with coenzyme Q10 could increase the beneficial effects of statin therapy in hemodialysis patients.

In this study, we will test to see if different doses of the dietary supplement coenzyme Q10 will be safe and well tolerated in hemodialysis patients. This is with a view to later studies to determine if coenzyme Q10 will help stop harmful chemical reactions in the blood for hemodialysis patients. This study will help us prepare for future studies of coenzyme Q10, by demonstrating the safely and tolerability of this compound in hemodialysis patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Safety, Tolerability and Efficacy of Coenzyme Q10 in Hemodialysis Patients: Aim 1

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

Safety Measures: * Laboratory tests on serum: Comprehensive metabolic panel and creatinine phosphokinase. * Electrocardiogram, physical examination findings, and adverse events. [Every two weeks]
Efficacy Measures: Markers in the blood indicating "oxidative stress" [Every two weeks]

Secondary Outcome Measures

Serum biomarkers of Cardiovascular condition and health [At baseline study visit and last study visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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