Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

April 20, 2012 updated by: Jonathan Himmelfarb, University of Washington

Safety, Tolerability and Efficacy of Coenzyme Q10 in Hemodialysis Patients: Aim 1

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98122
        • Northwest Kidney Centers - Scribner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum biomarkers of Cardiovascular condition and health
Time Frame: At baseline study visit and last study visit
At baseline study visit and last study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jonathan Himmelfarb, MD, University of Washington - Kidney Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 21, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35580-D
  • R21AT004265-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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