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Completed

NCT Number: NCT02847585

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

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.

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Key information

Age range

1 month–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-soluble Ubiquinol

Dietary Supplement

10 mg/kg BW/d, by oral drops

Primary outcomes

  1. Left ventricular ejection fraction

    Time frame: 6 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2016
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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