Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

University of Delaware

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: MitoQ

Study type: Interventional

Funder types: Other

Identifiers

NCT02364648

680076-2

Details and patient eligibility

About

The purpose of this study is to examine the effect of mitochondria derived oxidative stress on vascular function in patients with moderate to severe Chronic Kidney Disease.

Full description

Chronic Kidney Disease (CKD) patients are at increased risk of cardiovascular disease. Endothelial dysfunction, characterized by a reduced bioavailability in nitric oxide, is an independent predictor of cardiovascular disease in CKD. Increased oxidative stress is a potential cause of endothelial dysfunction in this patient cohort. This study investigates the role that mitochondrial derived oxidative stress plays in CKD related vascular dysfunction. In a controlled, double blinded trial, Stage 3-5 CKD patients will be randomly assigned to receive a 4 week daily dose of a mitochondria targeted antioxidant (MitoQ) or a placebo.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage 3 - 5 Chronic Kidney Disease

Exclusion criteria

• History of cardiovascular disease;
• Current pregnancy;
• Uncontrolled hypertension;
• Uncontrolled hyperlipidemia;
• Current hormone replacement therapy;
• Current use of tobacco products;
• Elevated liver enzymes;
• Current autoimmune disease;
• Daily use of of antioxidants >300mg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

MitoQ

Experimental group

Description:

4 week 20mg oral daily dose of MitoQ

Treatment:

Dietary Supplement: MitoQ

Placebo

Placebo Comparator group

Description:

4 week 20mg oral daily placebo

Treatment:

Dietary Supplement: Placebo