Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000088640
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
5/08/2005
Date last updated
14/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of fish oil and coenzyme Q10 on cardiovascular risk in chronic renal failure
Scientific title
Effects of fish oil and coenzyme Q10 on cardiovascular risk in chronic renal failure
Secondary ID [1] 287487 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Fish-CoQ Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with mild renal impairment 168 0
Condition category
Condition code
Renal and Urogenital 188 188 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is of a factorial design. Subjects will be randomly allocated to include either fish oil (Omacor) or placebo (olive oil) capsules whilst maintaining normal dietary habits and physical activity. Within each of these groups, subjects will be further randomised to receive supplements of Coenzyme Q10 (CoQ) or placebo. The intervention will be 8 weeks. The dose of oil in both placebo and fish oil capsules will be 4 g/day. This dose of oil will have minimal contribution towards total energy intake. The fish oil capsules (Omacor, 1g, Solvay Pharmaceuticals, Australia) contain approximately 90% n3 fatty acids (46% EPA and 38% DHA) and 4 mg/g alpha tocopherol. This dosage provides 3.6 g per day total n3 fatty acids, which equates to about one oily fish meal per day. CoQ will be given as 100 mg twice daily (Blackmores, Australia,). Capsules will not be taken on the morning of measurements of vascular function and blood sampling in order to avoid the possibility of acute effects.
Intervention code [1] 87 0
None
Comparator / control treatment
Placebo (olive oil) capsules
Control group
Placebo

Outcomes
Primary outcome [1] 227 0
To determine whether a combined approach including fish oil supplementation and coenzyme-Q10 (CoQ) has additive effects in improving blood pressure, vascular function and arterial compliance. A beneficial alteration of the serum lipid profile is also anticipated.
Timepoint [1] 227 0
Measurements will be performed during the last week of baseline and the last week of intervention.
Secondary outcome [1] 514 0
To determine whether the combination of fish oil supplementation and coenzyme-Q10, has beneficial effects on ventricular function, markers of inflammation and oxidative stress.
Timepoint [1] 514 0
Measurements will be performed during the last week of baseline and the last week of intervention.
Secondary outcome [2] 317571 0
To determine whether the combination of fish oil supplementation and coenzyme-Q10, affects leukocyte telomere length.
Timepoint [2] 317571 0
Measurements will be performed from samples taken during the last week of baseline and the last week of the intervention. These new analyses will take place on samples which have been kept in storage at -80C.
Secondary outcome [3] 317572 0
To determine whether the combination of fish oil supplementation and coenzyme-Q10, affects fatty acid cytochrome P450 metabolites associated with blood pressure control.
Timepoint [3] 317572 0
Measurements will be performed from samples taken during the last week of baseline and the last week of the intervention. These new analyses will take place on samples which have been kept in storage at -80C.
Secondary outcome [4] 341368 0
To determine whether the combination of fish oil supplementation and coenzyme-Q10, affects pro-resolving lipid mediators of inflammation resolution in neutrophils stimulated ex vivo.
Timepoint [4] 341368 0
These new analyses will take place on samples which have been kept in storage at -80C. Samples will be measured at baseline and end of intervention.

Eligibility
Key inclusion criteria
Evidence of impaired GFR (>20 and <80 ml/min), serum creatinine <350umol/L and haemoglobin >110g/L. Patients receiving antihypertensive or lipid-lowering medication will not be excluded.
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Angina pectoris; major surgery, a cardiovascular event or diagnosis of symptoms < 3 months; BP >170/100mmHg; diabetes; liver disease; current smokers; regular non-steroidal anti-inflammatory drug therapy; eating > 1 fish meal / week or regularly taking fish oil supplements; and consuming an average > 4 standard alcoholic drinks / day.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by a statistician not involved with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization. Sequence generated using Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2004
Actual
5/01/2004
Date of last participant enrolment
Anticipated
Actual
15/10/2006
Date of last data collection
Anticipated
Actual
20/12/2006
Sample size
Target
120
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 245 0
Government body
Name [1] 245 0
NH&MRC
Country [1] 245 0
Australia
Primary sponsor type
Individual
Name
Dr Trevor A Mori
Address
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 182 0
Individual
Name [1] 182 0
Professor Gerald Watts
Address [1] 182 0
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country [1] 182 0
Australia
Secondary sponsor category [2] 183 0
Individual
Name [2] 183 0
Professor Ian Puddey
Address [2] 183 0
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country [2] 183 0
Australia
Secondary sponsor category [3] 184 0
Individual
Name [3] 184 0
Dr Ashley Irish
Address [3] 184 0
Renal Unit, Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country [3] 184 0
Australia
Secondary sponsor category [4] 185 0
Individual
Name [4] 185 0
Professor Lawrence Beilin
Address [4] 185 0
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country [4] 185 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1042 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 1042 0
Ethics committee country [1] 1042 0
Australia
Date submitted for ethics approval [1] 1042 0
Approval date [1] 1042 0
29/01/2004
Ethics approval number [1] 1042 0
Ethics committee name [2] 1043 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [2] 1043 0
Ethics committee country [2] 1043 0
Australia
Date submitted for ethics approval [2] 1043 0
Approval date [2] 1043 0
16/12/2004
Ethics approval number [2] 1043 0

Summary
Brief summary
The study aims to determine if supplementation with fish oils or the vitamin coenzyme Q10, or a combination of both, will lead to beneficial effects on blood pressure and heart disease risk in patients with renal impairment.
Heart disease is one of the main causes of death in Australia. People with renal impairment are at increased cardiovascular risk due to the coexistence of hypertension (high blood pressure), blood lipid abnormalities (blood fats) and increased inflammation. One approach may be to complement drug treatment of renal impairment with non-drug measures such as nutrition and lifestyle factors. In this regard, fish oils have great clinical potential in the treatment of renal impairment and its associated complications. Fish oils reduce blood pressure and improve blood vessel wall elasticity. They improve blood fats, reduce the tendency of blood to clot and reduce inflammation. Coenzyme Q10 is a vitamin that plays a critical role in cell function. It improves blood pressure, blood vessel and heart function, and glucose control.
Trial website
Trial related presentations / publications
Mori TA, Burke V, Puddey IB, Irish AB, Cowpland CA, Beilin LJ, Dogra GK, Watts GF. The effects of ?3 fatty acids & coenzyme Q10 on blood pressure and heart rate in chronic kidney disease: a randomized controlled trial. Journal of Hypertension 2009; 27: 1863–1872.

Barden AE, Burke V, Mas E, Beilin LJ, Puddey IB, Watts GF, Irish AB, Mori TA. n-3 Fatty acids reduce plasma 20-hydroxyeicosatetraenoic acid and blood pressure in patients with chronic kidney disease. Journal of Hypertension 2015, 33(9): 1947-1953.

Mas E, Barden A, Burke V, Beilin LJ, Watts GF, Puddey IB, Irish AB, Mori TA. A randomized controlled trial of the effects of n-3 fatty acids on resolvins in chronic kidney disease. Clinical Nutrition 2016; 35(2): 331-336.

Barden A, O'Callaghan N, Burke V, Mas E, Beilin LJ, Fenech M, Irish AB, Watts GF, Puddey IB, Huang R-C, Mori TA. n-3 Fatty Acid supplementation and leukocyte telomere length in patients with chronic kidney disease. Nutrients 2016, 8(3): 175; (Pages 1-11) doi:10.3390/nu8030175
Public notes

Contacts
Principal investigator
Name 36161 0
Prof Trevor A Mori
Address 36161 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth Australia 6847
Country 36161 0
Australia
Phone 36161 0
61892240273
Fax 36161 0
Email 36161 0
[email protected]
Contact person for public queries
Name 9276 0
Dr Trevor A Mori
Address 9276 0
GPO Box X2213
Perth WA 6847
Country 9276 0
Australia
Phone 9276 0
+61 8 92240273
Fax 9276 0
+61 8 92240246
Email 9276 0
[email protected]
Contact person for scientific queries
Name 204 0
Dr Trevor A Mori
Address 204 0
GPO Box X2213
Perth WA 6847
Country 204 0
Australia
Phone 204 0
+61 8 92240273
Fax 204 0
+61 8 92240246
Email 204 0
[email protected]

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

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