ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000608268

Ethics application status

Approved

Date submitted

8/07/2009

Date registered

22/07/2009

Date last updated

6/07/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Relationship between time course and dose of vitamin E and oxidative stress in haemodialysis patients: a randomised controlled trial

Scientific title

Relationship between time course and dose of vitamin E and oxidative stress in haemodialysis patients: a randomised controlled trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oxidative stress in hemodialysis patients

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Vitamin E (natural (RRR) alpha tocopherol )
Arm 1
a Dose 1600IU/day
b Duration 20 weeks
c Mode of administration oral capsule
Arm 2
a Doses 100IU, 200IU, 400IU, 800IU and 1600IU/day
b Duration maximum 20 weeks
c Oral capsule

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo treated group (Safflower oil)
a once daily
b Duration 20 weeks
c Mode of administration oral capsule

Control group

Placebo

Outcomes

Primary outcome [1]

Levels of oxidative stress measured by blood F2 isoprostanes

Timepoint [1]

In the time course study we will continue for 20 bloods will be measured at baseline then every two weeks for 20 weeks
In the dose determining study the time point will be no longer than 20 weeks with bloods taken at baseline then two weekly for 20 weeks

Secondary outcome [1]

nil

Timepoint [1]

nil

Eligibility

Key inclusion criteria

Incident and prevalent hemodialysis patients undergoing regular three times per week dialysis
Patients must have elevated oxidative stress defined as F2 isoprostane level > 100 pg/ml

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients currently taking vitamin E or having taken it in the previous three months will be excluded
Patients taking warfarin, desimipramine, chlorpromazine and chloroquine will be excluded

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)

Eligible patients will be approached and consented by investigators. Randomization will be conducted by a person who is independent of the study. Identical coded containers of vitamin E or placebo will be dispensed according to randomization code by blinded independent staff.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random numbers placed in opaque envelopes with dispensing codes.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Nil

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Renal Research

Address [1]

Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston
Brisbane
QLD 4029

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Cognis Pty Ltd

Address

Cognis Nutrition & Health
168B Newton Road Wetherill Park NSW 2164

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Address [1]

Associate Professor Jeff Coombes
School of Human Movement Studies
The University of Queensland
St Lucia
QLD 4000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee

Ethics committee address [1]

Royal Brisbane and Women's Hospital
Brisbane QLD
4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/07/2009

Ethics approval number [1]

HREC/09/QRBW/71

Summary

Brief summary

Background: Oxidative stress and inflammation are associated with increased cardiovascular morbidity and mortality particularly in patients with end stage kidney disease. Observational data support the contention that increased antioxidant intake with nutrients such as vitamin E is correlated with reduced cardiovascular morbidity and mortality in the general population. Unfortunately, most clinical intervention trials using vitamin E have failed to support this relationship. The SPACE study conducted in hemodialysis patients had a positive outcome however this has not been translated into clinical practice perhaps because of the negativity generated from studies in the general population. The failure of studies using vitamin E other than the SPACE study may simply be as a consequence of choosing the wrong form of Vitamin E, prescribed at the wrong dose, for the wrong duration to the wrong patients. Future research in this area should focus on treating patients with established measured abnormalities of oxidative stress, with a safe vitamin E formulation that is proven to be effective, at least in part, in reversing the observed oxidative stress abnormalities. 
Methods: Therefore, the aim of this study is to investigate the effect of different doses of vitamin E supplementation on oxidative stress markers in hemodialysis patients with proven abnormalities of oxidative stress. The study will consist of a time-course study and a dose-ranging study. In the time course study eight patients will be required to take 1600 IU/day natural (RRR) alpha tocopherol for 20 weeks. Blood will be collected every two weeks and analysed for a marker of oxidative stress (plasma isoprostanes) and alpha tocopherol. The optimum time period to decrease oxidative stress (by 50%) will be determined from this study. It is hypothesised that this will occur within 16 weeks. In the dose-ranging study 48 patients will be randomised to either placebo, 100IU/day, 200IU/day, 400IU/day, 800IU/day or 1600IU/day of natural (RRR) alpha tocopherol for a time period determined from the time course study. Blood will be collected at baseline and at the end of the study and analysed for a plasma isoprostanes and alpha tocopherol. It is hypothesised that doses =800 IU of vitamin E will be required to decrease oxidative stress by 50%.

Trial website

nil

Trial related presentations / publications

nil

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Robert Fassett

Address

Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston
Brisbane
QLD 4029

Country

Australia

Phone

+61 419399571

Fax

+61 7 36368572

r.fassett@uq.edu.au

Contact person for scientific queries

Name

Professor Robert Fassett

Address

Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston
Brisbane
QLD 4029

Country

Australia

Phone

+61 419399571

Fax

+61 7 36368572

r.fassett@uq.edu.au

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.

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