CoQ10 Biomarker Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan Himmelfarb, University of Washington
ClinicalTrials.gov Identifier:
NCT01408680
First received: July 25, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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

Condition Intervention
Oxidative Stress
Inflammation
Endothelial Dysfunction
Dietary Supplement: Coenzyme Q10
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change from Baseline in Oxidative Stress Status at 1 month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 1-month visit.

  • Change from Baseline in Oxidative Stress Status at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 2-month visit.

  • Change from Baseline in Oxidative Stress Status at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 4-month visit.


Secondary Outcome Measures:
  • Change from Baseline in Inflammatory Status at 1 month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 1-month visit.

  • Change from Baseline in Inflammatory Status at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 2-month visit.

  • Change from Baseline in Inflammatory Status at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 4-month visit.

  • Change from Baseline in Endothelial Function at 1 month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 1-month visit.

  • Change from Baseline in Endothelial Function at 2 months [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 2-month visit.

  • Change from Baseline in Endothelial Function at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 4-month visit.


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Coenzyme Q10 600 mg Dietary Supplement: Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
Other Name: CoQ10
Active Comparator: Coenzyme Q10 1200 mg Dietary Supplement: Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
Other Name: CoQ10
Placebo Comparator: Placebo Dietary Supplement: Placebo
Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.

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.

  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 or ≤ 85 years
  • Life expectancy greater than one year
  • Ability to understand and provide informed consent for participation in the study

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 > 150 mg/day or other antioxidant or nutritional supplements
  • Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
  • Patients hospitalized for more than 5 days within the past 30 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
  • Pregnancy
  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: NCT01408680

Contacts
Contact: Lori Linke, DTR 206-616-8574 loril@nwkidney.org

Locations
United States, Washington
Northwest Kidney Centers Recruiting
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: NCT01408680     History of Changes
Other Study ID Numbers: 40428-A, R21AT004265
Study First Received: July 25, 2011
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
End-stage Renal Disease
Hemodialysis
Cardiovascular Disease
Antioxidants
Atherosclerosis
Coenzyme Q10

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on July 29, 2014