Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy

July 10, 2018 updated by: Yeh, Chung Shan Medical University
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.

Exclusion Criteria:

  • Hypertension
  • Arrhythmia
  • Congenital heart defects
  • Acute myocarditis
  • Pregnant and lactating teens
  • Antioxidant vitamins users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label
water-soluble ubiquinol
Dietary supplement: Water-soluble Ubiquinol
10 mg/kg BW/d, by oral drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: 6 months
Left ventricular ejection fraction (%) will be measured by cardiac echo.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of plasma coenzyme Q10
Time Frame: 6 months
Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.
6 months
B-type natriuretic peptide (BNP)
Time Frame: 6 months
BNP (pg/mL) will be measured by fluorescence immunoassay.
6 months
malondialdehyde (MDA)
Time Frame: 6 months
MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.
6 months
catalase (CAT)
Time Frame: 6 months
red blood cells level of CAT in unit/mg protein.
6 months
glutathione peroxide (GPx)
Time Frame: 6 months
red blood cells level of GPx in unit/mg protein.
6 months
superoxide dismutase (SOD)
Time Frame: 6 months
red blood cells level of SOD in unit/mg protein.
6 months
high sensitivity C-reactive protein (hs-CRP)
Time Frame: 6 months
hs-CRP (mg/dL) will be measured by Immunoturbidimetry.
6 months
high sensitivity interleukin-6 (IL-6)
Time Frame: 6 months
IL-6 (pg/dL) will be measured by immunosorbent assay.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Ping-Ting Lin, Ph.D., School of Nutrition, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

July 6, 2018

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOST105-2628-B-040-MY2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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