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

Not Applicable

Completed

• Conditions: Pediatric Dilated Cardiomyopathy
• Interventions: Dietary Supplement: Water-soluble Ubiquinol

• Registration Number: NCT02847585
• Lead Sponsor: Chung Shan Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-08-01
• Primary Completion: 2018-05-30
• Status Verified: 2018-07
• Study Completion: 2018-07-06
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label	Water-soluble Ubiquinol	water-soluble ubiquinol

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction	6 months	Left ventricular ejection fraction (%) will be measured by cardiac echo.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan