NCT01408680

CoQ10 Biomarker Trial

Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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

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 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.

Conditions

• Oxidative Stress
• Inflammation
• Endothelial Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Coenzyme Q10	Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
DIETARY_SUPPLEMENT	Coenzyme Q10	Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
DIETARY_SUPPLEMENT	Placebo	Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2011-08-03
• Last updated: 2014-12-04

Locations

1 site across 1 country: United States