Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
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Purpose
Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA) indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes of this study are going to investigate the relation of coenzyme Q10 with other antioxidant vitamins (Vitamin A, C, and E), the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients during Statin therapy. The study is going to design a placebo-controlled study. The investigators will recruit coronary artery disease (CAD) patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and healthy subjects. CAD subjects which recruit form the first year are dived into two groups by LDL-C level (LDL-C < 100 mg/dL and 100-130 mg/dL), than randomly assign to placebo and coenzyme Q10 supplements (150 mg/bid = 300 mg/d) groups (n = 20/group). Intervention is going to administration for six months. Fasting blood will be obtained in each month and determine the concentration of antioxidant vitamins, lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the investigators will measure the level of inflammatory markers in all subjects of this study. Hopefully, the results of this study could provide information of coenzyme Q10 supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Dietary Supplement: Coenzyme Q10 Other: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
- Antioxidant and inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The study are going to measure the concentrations of coenzyme Q10, vitamin A, C, E, lipid peroxidation markers (TBARS, ox-LDL, F2-isoprostane and 8-OHdG) and antioxidant enzymes activities (TEAC, catalase, glutathione peroxidase, glutathione reductase and superoxide dismutase), and the level of inflammatory markers (hs-CRP, TNF-alfa, IL-1, IL-6 and adiponectin, ICAM-1, VCAM-1) in all subjects of this study.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Placebo
Placebo:starch
|
Other: Placebo
Placebo :starch
Other Name: Placebo
|
| Experimental: Coenzyme Q10 |
Dietary Supplement: Coenzyme Q10
Coenzyme Q10 300 mg/d (150 mg/bid)
Other Name: Ubquionine
|
Eligibility| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery and under statin therapy.
Exclusion Criteria:
- age < 18 years old
- pregnancy women
- taking antioxidant vitamins supplements
Contacts and Locations| Contact: Ping-Ting Lin, Ph.D. | +886-4-24730022 ext 12187 | apt810@csmu.edu.tw |
| Taiwan | |
| Taichung Verterans General Hospital | Recruiting |
| Taichung, Taiwan | |
| Contact: Ping-Ting Lin, Ph.D. +886-4-24730022 ext 12187 apt810@csmu.edu.tw | |
More Information
No publications provided
| Responsible Party: | Taichung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT01424761 History of Changes |
| Other Study ID Numbers: | S10241 |
| Study First Received: | August 24, 2011 |
| Last Updated: | August 26, 2011 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |
ClinicalTrials.gov processed this record on May 23, 2013