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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Dietary Supplement: Coenzyme Q10
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Reducing lipid peroxidation and increasing antioxidant enzyme activities [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pill Other: Placebo
Placebo controlled (dextrin)
Experimental: Coenzyme Q10 Dietary Supplement: Coenzyme Q10
coenzyme Q10 supplements 60 mg/day and 150 mg/day

  Eligibility

Genders Eligible for Study:   Both
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

Exclusion Criteria:

  • age < 18 years old
  • pregnancy women
  • taking lowering lipid drug (Statin)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01163500

Locations
Taiwan
Taichung Verterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01163500     History of Changes
Other Study ID Numbers: S07240
Study First Received: July 13, 2010
Last Updated: October 10, 2013
Health Authority: Taiwan: Department of Health

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
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on October 19, 2014