Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01424761
First received: August 24, 2011
Last updated: June 10, 2013
Last verified: June 2013

August 24, 2011
June 10, 2013
August 2011
March 2013   (final data collection date for primary outcome measure)
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 and E, lipid peroxidation markers (TBARS) and antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the level of inflammatory markers (hs-CRP, TNF-alfa, IL-6 and adiponectin) in all subjects of this study.
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.
Complete list of historical versions of study NCT01424761 on ClinicalTrials.gov Archive Site
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Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
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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 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 are randomly assign to placebo and coenzyme Q10 supplements (150 mg/bid = 300 mg/d) groups. Intervention is going to administration for three 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.

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Coronary Artery Disease
  • Dietary Supplement: Coenzyme Q10
    Coenzyme Q10 300 mg/d (150 mg/bid)
    Other Name: Ubquionine
  • Other: Placebo
    Placebo :starch
    Other Name: Placebo
  • Experimental: Placebo
    Placebo:starch
    Intervention: Other: Placebo
  • Experimental: Coenzyme Q10
    Intervention: Dietary Supplement: Coenzyme Q10
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01424761
S10241
Yes
Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Not Provided
Taichung Veterans General Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP