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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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ClinicalTrials.gov Identifier: NCT01424761
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: Coenzyme Q10 Other: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : August 2011
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Placebo
Placebo:starch
Other: Placebo
Placebo :starch
Experimental: Coenzyme Q10 Dietary Supplement: Coenzyme Q10
Coenzyme Q10 300 mg/d (150 mg/bid)
Other Name: Ubquionine



Primary Outcome Measures :
  1. Antioxidant and inflammation [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT01424761


Locations
Taiwan
Taichung Verterans General Hospital
Taichung, Taiwan
Sponsors and Collaborators
Taichung Veterans General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01424761     History of Changes
Other Study ID Numbers: S10241
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

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
Vitamins