Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
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
Exclusion Criteria:
- age < 18 years old
- pregnancy women
- taking lowering lipid drug (Statin)
Sites / Locations
- Taichung Verterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Pill
Coenzyme Q10
Arm Description
Outcomes
Primary Outcome Measures
Reducing lipid peroxidation and increasing antioxidant enzyme activities
Secondary Outcome Measures
Full Information
NCT ID
NCT01163500
First Posted
July 13, 2010
Last Updated
October 10, 2013
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01163500
Brief Title
Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (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
Coenzyme Q10 (Ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the mitochondrial membrane and considered as a preventive factor for coronary artery disease (CAD). However, the relationships between coenzyme Q10 and the prevention of the risk of CAD are still inconsistent. The purposes of this study are to investigate the relation of coenzyme Q10 concentration with the blood lipid levels, plasma homocysteine, the markers of lipid peroxidation (TBARS, ox-LDL),antioxidant enzymes activities (catalase, glutathione peroxidase, superoxide dismutase)and to examine the association with the risk of CAD.The CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery (n = 100). The second year is a double-blind, placebo-controlled intervention study. CAD subjects (n = 60) are randomly assign to one of the three groups (coenzyme Q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). Intervention is going to administration for three months. The third year is a case-control study. The control group (n = 100) is comprised of healthy individuals with normal blood biochemical values, and match by age and gender with the first year CAD subjects (case group). Fasting blood samples will be obtain to determine the concentration of coenzyme Q10, homocysteine, the markers of lipid peroxidation,antioxidant enzymes activities. The differences between case and control groups will be compared by using Student's t-test. Conditional logistical regression model will be performed to calculate the odds ratio for CAD based on coenzyme Q10 level. Hopefully, the results of this study could provide the information to what has been know in CAD subjects. We expect coenzyme Q10 could be a preventive supplement to reduce the risk of CAD.
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
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pill
Arm Type
Placebo Comparator
Arm Title
Coenzyme Q10
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10
Intervention Description
coenzyme Q10 supplements 60 mg/day and 150 mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo controlled (dextrin)
Primary Outcome Measure Information:
Title
Reducing lipid peroxidation and increasing antioxidant enzyme activities
Time Frame
12 weeks
10. Eligibility
Sex
All
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
Exclusion Criteria:
age < 18 years old
pregnancy women
taking lowering lipid drug (Statin)
Facility Information:
Facility Name
Taichung Verterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
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