Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

Phase 4

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: MitoQ

• Registration Number: NCT02364648
• Lead Sponsor: University of Delaware

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Study Start: 2017-07-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	4 week 20mg oral daily placebo
MitoQ	MitoQ	4 week 20mg oral daily dose of MitoQ

Primary Outcome Measures

Name	Time	Method
Microvascular Function, assessed by laser Doppler flowmetry coupled with microdialysis	Change from baseline at 4 weeks	Nitric oxide mediated cutaneous microvascular dilatory response to local heating assessed by laser Doppler flowmetry coupled with microdialysis

Secondary Outcome Measures

Name	Time	Method
Conduit artery endothelial dependent dilation, assessed by duplex ultrasound	Change from baseline at 4 weeks	Brachial artery flow mediated dilation assessed by duplex ultrasound
Mitochondria derived superoxide, assessed by electron paramagnetic resonance spectroscopy	Change from baseline at 4 weeks	Plasma mitochondria superoxide assessed by electron paramagnetic resonance spectroscopy

Trial Locations

Locations (1)

Department of Kinesiology and Applied Physiology, University of Delaware; 🇺🇸 Newark, Delaware, United States