CoQ10 Biomarker Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients

Conditions
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Inflammation, Oxidative Stress, Endothelial Dysfunction

Intervention / Treatment
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* Dietary Supplement: Coenzyme Q10
* Dietary Supplement: Coenzyme Q10
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10 600 mg<br> | Dietary Supplement: Coenzyme Q10<br>* Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.<br>* Other names: CoQ10;|
| Active Comparator: Coenzyme Q10 1200 mg<br> | Dietary Supplement: Coenzyme Q10<br>* Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.<br>* Other names: CoQ10;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Oxidative Stress Status at 1 month | 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. | 1 month | 
| Change from Baseline in Oxidative Stress Status at 2 months | 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. | 2 months | 
| Change from Baseline in Oxidative Stress Status at 4 months | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Inflammatory Status at 1 month | 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. | 1 month | 
| Change from Baseline in Inflammatory Status at 2 months | 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. | 2 months | 
| Change from Baseline in Inflammatory Status at 4 months | 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. | 4 months | 
| Change from Baseline in Endothelial Function at 1 month | 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. | 1 month | 
| Change from Baseline in Endothelial Function at 2 months | 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. | 2 months | 
| Change from Baseline in Endothelial Function at 4 months | 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-stage Renal Disease, Hemodialysis, Cardiovascular Disease, Antioxidants, Atherosclerosis, Coenzyme Q10