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

Study Overview
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Brief Summary
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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
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Pediatric Dilated Cardiomyopathy

Intervention / Treatment
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* Dietary Supplement: Water-soluble Ubiquinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>water-soluble ubiquinol | Dietary Supplement: Water-soluble Ubiquinol<br>* 10 mg/kg BW/d, by oral drops<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy