CoQ10 Biomarker Trial
Condition: Oxidative Stress; Inflammation; Endothelial Dysfunction
MeSH terms: Inflammation
Study type: Interventional

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.
    

Intervention name(s): Coenzyme Q10; Coenzyme Q10; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.; Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.; Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
Other intervention name(s): CoQ10; CoQ10
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: End-stage Renal Disease; Hemodialysis; Cardiovascular Disease; Antioxidants; Atherosclerosis; Coenzyme Q10