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Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908297
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : April 24, 2012
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jonathan Himmelfarb, University of Washington

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Intervention Details:
  • Dietary Supplement: Coenzyme Q10

    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 Name: CoQ10

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

Secondary Outcome Measures :
  1. Serum biomarkers of Cardiovascular condition and health [ Time Frame: At baseline study visit and last study visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908297

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United States, Washington
Northwest Kidney Centers - Scribner
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Jonathan Himmelfarb, MD University of Washington - Kidney Research Institute
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jonathan Himmelfarb, Professor, University of Washington Identifier: NCT00908297    
Other Study ID Numbers: 35580-D
R21AT004265-01A2 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012
Keywords provided by Jonathan Himmelfarb, University of Washington:
Cardiovascular disease
End stage renal disease
Oxidative stress
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs