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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Chung Shan Medical University

Current Primary Outcome: Left ventricular ejection fraction [ Time Frame: 6 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Chung Shan Medical University

Dates:
Date Received: July 12, 2016
Date Started: August 2016
Date Completion: July 2018
Last Updated: February 24, 2017
Last Verified: February 2017