Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 915 0
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 237182 0
Condition category
Condition code
Renal and Urogenital 237507 237507 0 0
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] 236889 0
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] 238317 0
Levels of oxidative stress measured by blood F2 isoprostanes
Timepoint [1] 238317 0
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] 244709 0
nil
Timepoint [1] 244709 0
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?
No
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
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237288 0
Hospital
Name [1] 237288 0
Renal Research
Country [1] 237288 0
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] 236771 0
University
Name [1] 236771 0
The University of Queensland
Address [1] 236771 0
Associate Professor Jeff Coombes
School of Human Movement Studies
The University of Queensland
St Lucia
QLD 4000
Country [1] 236771 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239389 0
Human Research Ethics Committee
Ethics committee address [1] 239389 0
Royal Brisbane and Women's Hospital
Brisbane QLD
4029
Ethics committee country [1] 239389 0
Australia
Date submitted for ethics approval [1] 239389 0
Approval date [1] 239389 0
03/07/2009
Ethics approval number [1] 239389 0
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 29864 0
Address 29864 0
Country 29864 0
Phone 29864 0
Fax 29864 0
Email 29864 0
Contact person for public queries
Name 13111 0
Professor Robert Fassett
Address 13111 0
Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston
Brisbane
QLD 4029
Country 13111 0
Australia
Phone 13111 0
+61 419399571
Fax 13111 0
+61 7 36368572
Email 13111 0
[email protected]
Contact person for scientific queries
Name 4039 0
Professor Robert Fassett
Address 4039 0
Renal Medicine
Level 9 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston
Brisbane
QLD 4029
Country 4039 0
Australia
Phone 4039 0
+61 419399571
Fax 4039 0
+61 7 36368572
Email 4039 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

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

Documents added automatically
No additional documents have been identified.