Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01163500
First received: July 13, 2010
Last updated: October 10, 2013
Last verified: October 2013

July 13, 2010
October 10, 2013
July 2008
March 2009   (final data collection date for primary outcome measure)
Reducing lipid peroxidation and increasing antioxidant enzyme activities [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01163500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Coenzyme Q10 in Relation of the Lipid Peroxidation, Antioxidant Enzyme Activities in Coronary Artery Disease Patients
Not Provided

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.

Not Provided
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 supplements 60 mg/day and 150 mg/day
  • Other: Placebo
    Placebo controlled (dextrin)
  • Placebo Comparator: Pill
    Intervention: Other: Placebo
  • Experimental: Coenzyme Q10
    Intervention: Dietary Supplement: Coenzyme Q10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2009
March 2009   (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

Exclusion Criteria:

  • age < 18 years old
  • pregnancy women
  • taking lowering lipid drug (Statin)
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01163500
S07240
Yes
Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Not Provided
Taichung Veterans General Hospital
October 2013

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