Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000232235
Ethics application status
Approved
Date submitted
22/11/2008
Date registered
8/05/2009
Date last updated
8/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to Investigate the Effects of Coenzyme Q10 Supplementation on Cardiovascular Health in Males Receiving Statin Medication for High Cholesterol Levels
Scientific title
Randomised, double blind, placebo controlled, cross over study to investigate the effect of dietary supplementation with coenzyme Q10 on endothelial function in males with the metabolic syndrome who are concurrently on statin treatment.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 4006 0
Condition category
Condition code
Metabolic and Endocrine 4207 4207 0 0
Metabolic disorders
Cardiovascular 4208 4208 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coenzyme Q10 dietary supplement is a tablet (100mg) to be taken orally, twice daily for 3 months. There is a 1 month washout period between intervention and control or vice versa depending on treatment allocation.
Intervention code [1] 3731 0
Treatment: Other
Comparator / control treatment
Placebo is a sugar pill to be taken orally as 2 tablets twice daily for 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 5101 0
Flow-mediated dilation of the brachial artery (endothelium dependent function) to be assessed with ultrasound.
Timepoint [1] 5101 0
At baseline and at 3 months after intervention commencement
Secondary outcome [1] 8573 0
Endothelial independent dilation of the brachial artery to be assessed with ultrasound.
Timepoint [1] 8573 0
At baseline and at 3 months after intervention commencement
Secondary outcome [2] 8574 0
Augmentation index using a medical device with a pressure sensor to measure the siffness of the blood vessels.
Timepoint [2] 8574 0
At baseline and at 3 months after intervention commencement
Secondary outcome [3] 8575 0
Systolic and diastolic blood pressure assessed with an automated blood pressure monitor.
Timepoint [3] 8575 0
At baseline and at 3 months after intervention commencement
Secondary outcome [4] 8576 0
Markers of cardiovascular risk measured from blood tests.
Timepoint [4] 8576 0
At baseline and at 3 months after intervention commencement
Secondary outcome [5] 8577 0
Coenzyme Q10 levels measured from a blood test.
Timepoint [5] 8577 0
At baseline and at 3 months after intervention commencement
Secondary outcome [6] 8578 0
Quality of Life Scores assessed using a Quality of Life Questionnaire.
Timepoint [6] 8578 0
At baseline and at 3 months after intervention commencement

Eligibility
Key inclusion criteria
Waist circumference >= 94cm
Triglycerides >=1.7 mmol/L or specific therapy for tirglycerides
Systolic blood presure >=130 mmHg or Diastolic blood pressure >=85 mmHg or treatment for hypertension
Statin naive or treatment with <=40mg/day simvastatin or equivalent
Minimum age
35 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-treatment Low-density Lipoprotein (LDL)-cholesterol <1.5mmol/L or >6.5 mmol/L
Pre-treatment triglycerides >5 mmol/L
History of cardiovascular event or intervention within the 6 months prior to screening
Type 1 diabetes mellitus
Type 2 diabetes mellitus requiring oral anti-diabetic agents or insulin
Current smoker
Treatment with fibrates or other lipid modifying agents other than statin therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1396 0
New Zealand
State/province [1] 1396 0

Funding & Sponsors
Funding source category [1] 4196 0
Charities/Societies/Foundations
Name [1] 4196 0
National Heart Foundation of New Zealand (NZ)
Country [1] 4196 0
New Zealand
Primary sponsor type
Hospital
Name
Lipid and Diabetes Research Group
Address
First Floor, Hagley Hostel
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 3770 0
Hospital
Name [1] 3770 0
Clinical Biochemistry Unit
Address [1] 3770 0
Canterbury Health Laboratories
Corner Hagley Ave and Tuam Street
P O Box 151
Christchurch 8140
Country [1] 3770 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6253 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 6253 0
Ethics committee country [1] 6253 0
New Zealand
Date submitted for ethics approval [1] 6253 0
Approval date [1] 6253 0
Ethics approval number [1] 6253 0
URB/05/06/077

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29153 0
Address 29153 0
Country 29153 0
Phone 29153 0
Fax 29153 0
Email 29153 0
Contact person for public queries
Name 12310 0
Jo Young
Address 12310 0
Lipid and Diabetes Research Group
First Floor, Hagley Hostel
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 12310 0
New Zealand
Phone 12310 0
+64 3 364 1186
Fax 12310 0
+64 3 364 0457
Email 12310 0
joanna.young@cdhb.govt.nz
Contact person for scientific queries
Name 3238 0
Jo Young
Address 3238 0
Lipid and Diabetes Research Group
First Floor, Hagley Hostel
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 3238 0
New Zealand
Phone 3238 0
+64 3 364 1186
Fax 3238 0
+64 3 364 0457
Email 3238 0
joanna.young@cdhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.