Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2011-11-30
2013-12-31
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Coenzyme Q10 600 mg
Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
Coenzyme Q10 1200 mg
Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
Placebo
Placebo
Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
Interventions
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Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
Coenzyme Q10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
Placebo
Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prisoners, patients with significant mental illness, and other vulnerable populations
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Washington
OTHER
Responsible Party
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Jonathan Himmelfarb
Professor
Principal Investigators
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Jonathan Himmelfarb, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington, Kidney Research Institute
Locations
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Northwest Kidney Centers
Seattle, Washington, United States
Countries
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References
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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
Related Links
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The mission of Northwest Kidney Centers is to promote the optimal health, quality of life and independence of people with kidney disease, through patient care, education and research.
The Kidney Research Institute is a collaboration between Northwest Kidney Centers and UW Medicine focused on developing early detection, prevention and treatment of kidney disease and its complications.
Other Identifiers
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40428-A
Identifier Type: -
Identifier Source: org_study_id