CoQ10 Biomarker Trial

University of Washington

Status

Completed

Conditions

Inflammation

Endothelial Dysfunction

Oxidative Stress

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Coenzyme Q10

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01408680

40428-A

R21AT004265 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health.

In this study, the investigators hypothesize that administration of coenzyme Q10, as a targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by hemodialysis patients. This will lead to improvements in biomarkers of:

oxidative stress status
inflammatory status
endothelial dysfunction

Full 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 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, the investigators have no treatments proven to help prevent CVD in those on dialysis. For the general population, the investigators know about many factors that increase the risk of CVD, such as having a high level of "bad" cholesterol. But for people on dialysis, the investigators 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". The investigators 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 to other medicines. It is a strong antioxidant. The investigators already know that blood levels of coenzyme Q10 are lower 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.

In addition, many people take medications called "statins" to help reduce risk for cardiovascular disease. The investigators 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 taking coenzyme Q10 could increase the good effects of statin medication in hemodialysis patients.

This study will not last long enough for us to look at the development of CVD in subjects. But the investigators will be able to look at biomarkers of oxidative stress, systemic inflammation, and endothelial function. The investigators know that these biomarkers tell us about uremia and other harmful chemical reactions in the blood. If coenzyme Q10 improves the biomarkers, then the investigators believe that it will also help prevent CVD in hemodialysis patients. Our goal is for improvements in cardiovascular risk for those on hemodialysis.

Enrollment

66 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 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 > 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