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

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Brief Title

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


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.
    



Study Type

Interventional


Primary Outcome

Left ventricular ejection fraction

Secondary Outcome

 Levels of plasma coenzyme Q10

Condition

Pediatric Dilated Cardiomyopathy

Intervention

Water-soluble Ubiquinol

Study Arms / Comparison Groups

 Open label
Description:  water-soluble ubiquinol

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

10

Start Date

August 1, 2016

Completion Date

July 6, 2018

Primary Completion Date

May 30, 2018

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
      

Gender

All

Ages

1 Month - 20 Years

Accepts Healthy Volunteers

No

Contacts

Ping-Ting Lin, Ph.D., , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT02847585

Organization ID

MOST105-2628-B-040-MY2


Responsible Party

Principal Investigator

Study Sponsor

Chung Shan Medical University


Study Sponsor

Ping-Ting Lin, Ph.D., Principal Investigator, School of Nutrition, Chung Shan Medical University


Verification Date

July 2018