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

July 25, 2011
February 3, 2012
November 2011
July 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01408680 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
CoQ10 Biomarker Trial
Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Oxidative Stress
  • Inflammation
  • Endothelial Dysfunction
  • Dietary Supplement: Coenzyme Q10
    Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
    Other Name: CoQ10
  • Dietary Supplement: Coenzyme Q10
    Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
    Other Name: CoQ10
  • Dietary Supplement: Placebo
    Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
  • Active Comparator: Coenzyme Q10 600 mg
    Intervention: Dietary Supplement: Coenzyme Q10
  • Active Comparator: Coenzyme Q10 1200 mg
    Intervention: Dietary Supplement: Coenzyme Q10
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Lori Linke, DTR 206-616-8574 loril@nwkidney.org
United States
 
NCT01408680
40428-A, R21AT004265
Yes
Jonathan Himmelfarb, University of Washington
University of Washington
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Jonathan Himmelfarb, MD University of Washington, Kidney Research Institute
University of Washington
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP