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临床试验/NCT02847585
NCT02847585已完成不适用

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

Chung Shan Medical University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Left ventricular ejection fraction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Month 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.

排除标准

  • Hypertension
  • Arrhythmia
  • Congenital heart defects
  • Acute myocarditis
  • Pregnant and lactating teens
  • Antioxidant vitamins users

研究组 & 干预措施

Open label

Experimental

water-soluble ubiquinol

干预措施: Water-soluble Ubiquinol (Dietary Supplement)

结局指标

主要结局

Left ventricular ejection fraction

时间窗: 6 months

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

次要结局

  • Levels of plasma coenzyme Q10(6 months)
  • B-type natriuretic peptide (BNP)(6 months)
  • glutathione peroxide (GPx)(6 months)
  • malondialdehyde (MDA)(6 months)
  • catalase (CAT)(6 months)
  • superoxide dismutase (SOD)(6 months)
  • high sensitivity C-reactive protein (hs-CRP)(6 months)
  • high sensitivity interleukin-6 (IL-6)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeh

Principal Investigator

Chung Shan Medical University

研究点 (2)

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