Mitochondrial Oxidative Stress and Vascular Health in Chronic Kidney Disease

NCT ID: NCT02364648

Last Updated: 2019-04-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MitoQ

4 week 20mg oral daily dose of MitoQ

Group Type EXPERIMENTAL

MitoQ

Intervention Type DIETARY_SUPPLEMENT

Mitochondria targeted antioxidant

Placebo

4 week 20mg oral daily placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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MitoQ

Mitochondria targeted antioxidant

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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David Edwards

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danielle L Kirkman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

David G Edwards, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Danielle L Kirkman, PhD

Role: CONTACT

302 831 4659

David G Edwards, PhD

Role: CONTACT

Facility Contacts

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David Edwards, PhD

Role: primary

Danielle Kirkman, PhD

Role: backup

Other Identifiers

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680076-2

Identifier Type: -

Identifier Source: org_study_id

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