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

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ClinicalTrials.gov Identifier: NCT02847585
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yeh, Chung Shan Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Dilated Cardiomyopathy Dietary Supplement: Water-soluble Ubiquinol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : July 6, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open label
water-soluble ubiquinol
 Dietary Supplement: Water-soluble Ubiquinol
10 mg/kg BW/d, by oral drops


Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: 6 months ]
    Left ventricular ejection fraction (%) will be measured by cardiac echo.


Secondary Outcome Measures :
  1. Levels of plasma coenzyme Q10 [ Time Frame: 6 months ]
    Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.

  2. B-type natriuretic peptide (BNP) [ Time Frame: 6 months ]
    BNP (pg/mL) will be measured by fluorescence immunoassay.

  3. malondialdehyde (MDA) [ Time Frame: 6 months ]
    MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.

  4. catalase (CAT) [ Time Frame: 6 months ]
    red blood cells level of CAT in unit/mg protein.

  5. glutathione peroxide (GPx) [ Time Frame: 6 months ]
    red blood cells level of GPx in unit/mg protein.

  6. superoxide dismutase (SOD) [ Time Frame: 6 months ]
    red blood cells level of SOD in unit/mg protein.

  7. high sensitivity C-reactive protein (hs-CRP) [ Time Frame: 6 months ]
    hs-CRP (mg/dL) will be measured by Immunoturbidimetry.

  8. high sensitivity interleukin-6 (IL-6) [ Time Frame: 6 months ]
    IL-6 (pg/dL) will be measured by immunosorbent assay.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847585


Locations
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Taiwan
Chung Shan Medical University
Taichung, Taiwan, 40201
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: Ping-Ting Lin, Ph.D. School of Nutrition, Chung Shan Medical University
More Information
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Responsible Party: Yeh, Principal Investigator, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT02847585    
Other Study ID Numbers: MOST105-2628-B-040-MY2
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yeh, Chung Shan Medical University:
water-soluble ubiquinol supplementation
pediatric cardiomyopathy
antioxidant
inflammation
complementary therapy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
 Cardiomegaly
Laminopathies
Genetic Diseases, Inborn