Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients
Condition: Cardiovascular Disease; End Stage Renal Disease; Atherosclerosis; Oxidative Stress
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

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

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.
    

Intervention name(s): Coenzyme Q10
Intervention type(s): Dietary Supplement
Intervention description(s): By mouth (wafer) once daily for duration of study (8 weeks).
Dose escalation:
300 mg for two weeks
600 mg for two weeks
1200 mg for two weeks
1800 mg for final two weeks
Other intervention name(s): CoQ10
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular disease; End stage renal disease; Atherosclerosis; Oxidative stress; Antioxidants