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

NCT02847585 | Completed DMC

• 1 other identifier: MOST105-2628-B-040-MY2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Dilated Cardiomyopathy

Keywords

water-soluble ubiquinol supplementation; pediatric cardiomyopathy; antioxidant; inflammation; complementary therapy

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction

  Left ventricular ejection fraction (%) will be measured by cardiac echo.

  6 months

Secondary Outcomes (8)

• Levels of plasma coenzyme Q10

  6 months

• B-type natriuretic peptide (BNP)

  6 months

• malondialdehyde (MDA)

  6 months

• catalase (CAT)

  6 months

• glutathione peroxide (GPx)

  6 months

Study Arms (1)

Open label

EXPERIMENTAL

water-soluble ubiquinol

Dietary Supplement: Water-soluble Ubiquinol

Interventions

Water-soluble Ubiquinol DIETARY_SUPPLEMENT

10 mg/kg BW/d, by oral drops

Open label

Eligibility Criteria

• Age: 1 Month - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping-Ting Lin, Ph.D.

  School of Nutrition, Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: May 30, 2018
• Study Completion: July 6, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)