Trial Review

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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
ACTRN12606000255583
Ethics application status
Approved
Date submitted
19/06/2006
Date registered
27/06/2006
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Low dose vitamin E and blood pressure
Scientific title
To investigate if low dose mixed tocopherols and sesame can reduce blood pressure in hypertensive individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 1232 0
Condition category
Condition code
Cardiovascular 1316 1316 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomised, double-blind, placebo controlled trial with a 6 week intervention period. Treatment arms are:
1. 50mg mixed tocopherol supplement + 10g placebo spread
2. Placebo supplement + 10g sesame spread
3. 50mg mixed tocopherol supplement + 10g sesame spread

Capsules will be taken once in the morning and once in the evening as 25mg capsules. 5g of spread will consumed once in the morning and in the evening along with the capsules.
Intervention code [1] 1149 0
Lifestyle
Comparator / control treatment
4. Placebo supplement + placebo spread
Control group
Placebo

Outcomes
Primary outcome [1] 1798 0
1. Blood pressure (24hr ambulatory blood pressure monitoring)
Timepoint [1] 1798 0
Measured at baseline and following 6 weeks intervention
Primary outcome [2] 1799 0
2. Serum & cellular tocopherol enrichment
Timepoint [2] 1799 0
Measured at baseline and following 6 weeks intervention
Secondary outcome [1] 3155 0
1. Oxidative stress (plasma & urinary F2-isoprostanes)
Timepoint [1] 3155 0
Measured at baseline and following 6 weeks intervention.
Secondary outcome [2] 3156 0
2. Cytochrome P450 activity
Timepoint [2] 3156 0
Measured at baseline and following 6 weeks intervention.
Secondary outcome [3] 3157 0
3. Inflammation
Timepoint [3] 3157 0
Measured at baseline and following 6 weeks intervention.

Eligibility
Key inclusion criteria
Hypertensive, either treated or untreated with a systolic blood pressure between 100-160 mmHg and a distolic blood pressure <100 mmHg (mean of 3 readings taken every 2 mins).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diabetes requiring medication2. Recent coronary/cerebrovascular event <6 months, or heart failure3. Bdy mass index >354. Use of pure vitamin E supplements5. Use of oral contraceptives or premenopausal6. Evidence of renal impairment7. Smoking8. Alcohol intake >40g/day men or 30g/day women9. Episodic use of non-steroidal anti-inflammatory medication.

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)
Sealed in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomisation using computer generated random numbers in variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study was stopped before it even went ahead due to multiple changes resulting in an entirely new project being developed.
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment outside Australia
Country [1] 357 0
New Zealand
State/province [1] 357 0

Funding & Sponsors
Funding source category [1] 1441 0
Government body
Name [1] 1441 0
NH&MRC
Country [1] 1441 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 1275 0
None
Name [1] 1275 0
N/A
Address [1] 1275 0
Country [1] 1275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2816 0
School of Medicine & Pharmacology Clinical Trials Unit at Royal Perth Hospital-University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 2816 0
Ethics committee country [1] 2816 0
Australia
Date submitted for ethics approval [1] 2816 0
Approval date [1] 2816 0
13/03/2006
Ethics approval number [1] 2816 0
RA/4/1/1355

Summary
Brief summary
The study is designed to look at the effect of supplementation with low dose mixed vitamin E and sesame, either alone on in combination on blood pressure in people who already have elevated blood pressure. The study will be double-blinded with both the study co-ordinator and participants blinded to the tocopherol treatment. However, because of a noticeable taste difference between the placebo spread and the sesame spread, this will not be able to be blinded
Trial website
Trial related presentations / publications
None.
Public notes

Contacts
Principal investigator
Name 35207 0
Address 35207 0
Country 35207 0
Phone 35207 0
Fax 35207 0
Email 35207 0
Contact person for public queries
Name 10338 0
Professor Kevin Croft
Address 10338 0
School of Medicine and Pharmacology (RPH)
University of Western Australia
Box X2213 GPO
Perth WA 6847
Country 10338 0
Australia
Phone 10338 0
+61 8 92240275
Fax 10338 0
+61 8 92240246
Email 10338 0
kcroft@cyllene.uwa.edu.au
Contact person for scientific queries
Name 1266 0
Professor Kevin Croft
Address 1266 0
School of Medicine and Pharmacology (RPH)
University of Western Australia
Box X2213 GPO
Perth WA 6847
Country 1266 0
Australia
Phone 1266 0
+61 8 92240275
Fax 1266 0
+61 8 92240246
Email 1266 0
kcroft@cyllene.uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.