Safety and Tolerability of Coenzyme Q10 in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan Himmelfarb, University of Washington
ClinicalTrials.gov Identifier:
NCT00908297
First received: May 21, 2009
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Cardiovascular Disease
End Stage Renal Disease
Atherosclerosis
Oxidative Stress
Dietary Supplement: Coenzyme Q10

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety, Tolerability and Efficacy of Coenzyme Q10 in Hemodialysis Patients: Aim 1

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety Measures: * Laboratory tests on serum: Comprehensive metabolic panel and creatinine phosphokinase. * Electrocardiogram, physical examination findings, and adverse events. [ Time Frame: Every two weeks ] [ Designated as safety issue: Yes ]
  • Efficacy Measures: Markers in the blood indicating "oxidative stress" [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum biomarkers of Cardiovascular condition and health [ Time Frame: At baseline study visit and last study visit ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908297

Locations
United States, Washington
Northwest Kidney Centers - Scribner
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jonathan Himmelfarb, MD University of Washington - Kidney Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Jonathan Himmelfarb, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00908297     History of Changes
Other Study ID Numbers: 35580-D, R21 AT004265-01A2
Study First Received: May 21, 2009
Last Updated: April 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Cardiovascular disease
End stage renal disease
Atherosclerosis
Oxidative stress
Antioxidants

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on August 28, 2014