Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Coenzyme Q10
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Taichung Verterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo
Coenzyme Q10
Arm Description
Placebo:starch
Outcomes
Primary Outcome Measures
Antioxidant and inflammation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01424761
First Posted
August 24, 2011
Last Updated
June 10, 2013
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01424761
Brief Title
Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo:starch
Arm Title
Coenzyme Q10
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Other Intervention Name(s)
Ubquionine
Intervention Description
Coenzyme Q10 300 mg/d (150 mg/bid)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo :starch
Primary Outcome Measure Information:
Title
Antioxidant and inflammation
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Taichung Verterans General Hospital
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24192015
Citation
Lee BJ, Tseng YF, Yen CH, Lin PT. Effects of coenzyme Q10 supplementation (300 mg/day) on antioxidation and anti-inflammation in coronary artery disease patients during statins therapy: a randomized, placebo-controlled trial. Nutr J. 2013 Nov 6;12(1):142. doi: 10.1186/1475-2891-12-142.
Results Reference
derived
Learn more about this trial
Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
We'll reach out to this number within 24 hrs