Pediatric Dilated Cardiomyopathy
Conditions
Keywords
water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy
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.
Interventions
DIETARY_SUPPLEMENTWater-soluble Ubiquinol
10 mg/kg BW/d, by oral drops
Sponsors
Chung Shan Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction | 6 months | Left ventricular ejection fraction (%) will be measured by cardiac echo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B-type natriuretic peptide (BNP) | 6 months | BNP (pg/mL) will be measured by fluorescence immunoassay. |
| 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. |
| Levels of plasma coenzyme Q10 | 6 months | Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography. |
| 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. |
| glutathione peroxide (GPx) | 6 months | red blood cells level of GPx in unit/mg protein. |
Countries
Taiwan
Outcome results
None listed