CoQ10 Biomarker Trial

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408680
• Other study ID #: 40428-A
• Secondary ID: R21AT004265
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: December 2, 2014
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Northwest Kidney Centers	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   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.
•   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.