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
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|Condition or disease||Intervention/treatment||Phase|
|Pediatric Dilated Cardiomyopathy||Dietary Supplement: Water-soluble Ubiquinol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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|
Experimental: Open label
Dietary Supplement: Water-soluble Ubiquinol
10 mg/kg BW/d, by oral drops
- Left ventricular ejection fraction [ Time Frame: 6 months ]Left ventricular ejection fraction (%) will be measured by cardiac echo.
- 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.
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|Ages Eligible for Study:||1 Month to 20 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.
- Congenital heart defects
- Acute myocarditis
- Pregnant and lactating teens
- Antioxidant vitamins users
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
|Chung Shan Medical University|
|Taichung, Taiwan, 40201|
|Principal Investigator:||Ping-Ting Lin, Ph.D.||School of Nutrition, Chung Shan Medical University|
|Responsible Party:||Yeh, Principal Investigator, Chung Shan Medical University|
|Other Study ID Numbers:||
|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|
water-soluble ubiquinol supplementation
Genetic Diseases, Inborn