Clinical trial NCT02847585: Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Dilated Cardiomyopathy
Keywords: water-soluble ubiquinol supplementation
pediatric cardiomyopathy
antioxidant
inflammation
complementary therapy
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: Levels of plasma coenzyme Q10
timeFrame: 6 months
measure: B-type natriuretic peptide (BNP)
timeFrame: 6 months
measure: malondialdehyde (MDA)
timeFrame: 6 months
measure: catalase (CAT)
timeFrame: 6 months
measure: glutathione peroxide (GPx)
timeFrame: 6 months
measure: superoxide dismutase (SOD)
timeFrame: 6 months
measure: high sensitivity C-reactive protein (hs-CRP)
timeFrame: 6 months
measure: high sensitivity interleukin-6 (IL-6)
timeFrame: 6 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: School of Nutrition, Chung Shan Medical University
name: Ping-Ting Lin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: