CoQ10 Biomarker Trial

NCT01408680 | Completed DMC

• 2 other identifiers: 40428-AR21AT004265
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oxidative Stress; Inflammation; Endothelial Dysfunction

Keywords

End-stage Renal Disease; Hemodialysis; Cardiovascular Disease; Antioxidants; Atherosclerosis; Coenzyme Q10

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change from Baseline in Inflammatory Status at 1 month

  1 month

• Change from Baseline in Inflammatory Status at 2 months

  2 months

• Change from Baseline in Inflammatory Status at 4 months

  4 months

• Change from Baseline in Endothelial Function at 1 month

  1 month

• Change from Baseline in Endothelial Function at 2 months

  2 months

Study Arms (3)

Coenzyme Q10 600 mg

ACTIVE COMPARATOR

Dietary Supplement: Coenzyme Q10

Coenzyme Q10 1200 mg

ACTIVE COMPARATOR

Dietary Supplement: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.

Also known as: CoQ10

Coenzyme Q10 600 mg

Placebo DIETARY_SUPPLEMENT

Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of poor adherence to hemodialysis or medical regimen
• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Northwest Kidney Centers

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• 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.

  PMID: 37916745 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Inflammation; Kidney Failure, Chronic; Cardiovascular Diseases; Atherosclerosis

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jonathan Himmelfarb, MD

  University of Washington, Kidney Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: August 3, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)