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

• Sponsor: Chung Shan Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02847585
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Left ventricular ejection fraction [6 months]

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

Secondary Outcome Measures

1. Levels of plasma coenzyme Q10 [6 months]

   Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.

2. B-type natriuretic peptide (BNP) [6 months]

   BNP (pg/mL) will be measured by fluorescence immunoassay.

3. malondialdehyde (MDA) [6 months]

   MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.

4. catalase (CAT) [6 months]

   red blood cells level of CAT in unit/mg protein.

5. glutathione peroxide (GPx) [6 months]

   red blood cells level of GPx in unit/mg protein.

6. superoxide dismutase (SOD) [6 months]

   red blood cells level of SOD in unit/mg protein.

7. high sensitivity C-reactive protein (hs-CRP) [6 months]

   hs-CRP (mg/dL) will be measured by Immunoturbidimetry.

8. high sensitivity interleukin-6 (IL-6) [6 months]

   IL-6 (pg/dL) will be measured by immunosorbent assay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University	Taichung		Taiwan	40201

Sponsors and Collaborators

• Chung Shan Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yeh, Principal Investigator, Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT02847585
• Other Study ID Numbers: MOST105-2628-B-040-MY2
• First Posted: Jul 28, 2016
• Last Update Posted: Jul 11, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yeh, Principal Investigator, Chung Shan Medical University: water-soluble ubiquinol supplementation; pediatric cardiomyopathy; antioxidant; inflammation; complementary therapy
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated

Study Results

No Results Posted as of Jul 11, 2018