Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000343404
Ethics application status
Not yet submitted
Date submitted
26/06/2007
Date registered
26/06/2007
Date last updated
22/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.
Scientific title
Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 1894 0
Condition category
Condition code
Metabolic and Endocrine 1989 1989 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Phospha-E - d-tocopheryl phosphate (2 doses 200 and 400IU) 2. Tocopherol Acetate (Cognis product Covitol-700; 1 dose at 200IU) All are admistered orally as 1 capsule daily for 12 weeks.
Intervention code [1] 1851 0
Treatment: Other
Comparator / control treatment
3. Placebo (evaluation is compared to a placebo 'no active' capsule).
Control group
Placebo

Outcomes
Primary outcome [1] 2810 0
To assess the effects of 2 doses of Phospha-E (200, 400IU) compared to placebo control and 1 dose of classical vitamin E (200IU) compared to placebo control, on biomarkers of inflammation by measuring changes in high sensitivity C-reactive protein (hsCRP) from baseline to 6 and 12 weeks post-randomisation.
Timepoint [1] 2810 0
Measurements will only be taken at baseline, 6 weeks and 12 weeks post-randomisation.
Secondary outcome [1] 4736 0
To assess the effects of 2 doses of Phospha-E (200 and 400IU) compared to placebo control and 1 dose of classical vitamin E (200IU) compared to placebo control, on the lipid profile by measuring absolute and percentage change in total cholesterol, triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL) from baseline to weeks 6 and 12 post-randomisation.
Timepoint [1] 4736 0
Measurements will only be taken at baseline, 6 weeks and 12 weeks post-randomisation.

Eligibility
Key inclusion criteria
Caucasians with a waist circumference of >102cm (40 inches) for men and >89cm (35 inches) for women.- plus 2 of the following: - type 2 diabetes (but not on medication) - fasting blood glucose between 6.1-7.0mmol/L. - impaired glucose tolerance, as determined in the preceeding months by a glucose tolerance test. - systolic blood pressure >135mmHg or diastolic blood pressure of >90mmHg. - fasted total cholesterol >5.2mmol/L - fasted triglycerides >1.7mmol/L - fasted LDL >3.4mmol/L - fasted HDL <1.036mmol/L for men and <1.295mmol/L for women. - hsCRP levels >3.0mg/L
Minimum age
35 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with significant impairment in renal and/or hepatic function as determined through pre-history-driven physical.- Subject has a creatine clearance of <60ml/min determined by Cockcroft-Gault's method.- Subject has had any gastric/bowel surgery.- Subject has known history of allergic responses to vitamin E.- Subject has taken hyperlipidemic, diabetic or hypertensive medication within the last 2 months.- Subject is pregnant or breast-feeding.- Subject has a high white blood cell count (WBC; greater than 15/high power field (hpf).

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)
Allocation concealment procedure - allocation involves contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table from a statistics book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patients are blinded and the people administering the treatments are blinded.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2130 0
Commercial sector/Industry
Name [1] 2130 0
Phosphagenics Limited
Country [1] 2130 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
90 William Street Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 1936 0
None
Name [1] 1936 0
n/a
Address [1] 1936 0
Country [1] 1936 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3925 0
Royal Adelaide Hospital,.
Ethics committee address [1] 3925 0
North Terrace, Adelaide SA 5005
Ethics committee country [1] 3925 0
Australia
Date submitted for ethics approval [1] 3925 0
19/09/2007
Approval date [1] 3925 0
Ethics approval number [1] 3925 0
Ethics committee name [2] 3926 0
Repatriation General Hospital Adelaide
Ethics committee address [2] 3926 0
Daws Road, Daw Park, Adelaide 5041
Ethics committee country [2] 3926 0
Australia
Date submitted for ethics approval [2] 3926 0
27/09/2007
Approval date [2] 3926 0
Ethics approval number [2] 3926 0
Ethics committee name [3] 3927 0
Lyell McEwen Hospital
Ethics committee address [3] 3927 0
Haydow Road, Elizabeth Vale, SA, 5112
Ethics committee country [3] 3927 0
Australia
Date submitted for ethics approval [3] 3927 0
05/09/2007
Approval date [3] 3927 0
Ethics approval number [3] 3927 0

Summary
Brief summary
The study is for subjects who have a condition called metabolic syndrome. Metabolic syndrome is a condition in which people may have a number of clinically determined symptoms such as abdominal obesity, high cholesterol (lipid) and glucose levels in the blood and high blood pressure, as well as others. Some people may have only some of these clinical symptoms while others may have more. These clinical observations, and the severity of them, are recognised in a number of well known disease states such as cardiovascular disease and diabetes.
Vitamin E has been around for decades and is widely used by people for its known antioxidant properties. D-alpha Tocopheryl Phosphate (Phospha-E™) has recently been discovered to be naturally occurring in the body (like vitamin E) and has shown promising effects in laboratory studies on inflammatory markers which are implicated in a number of disease states associated with a condition known as Metabolic Syndrome.
The purpose of this study is to see if D-alpha Tocopheryl Phosphate (Phospha-E™) has any effect on your metabolic syndrome. The study would like to determine if D-alpha Tocopheryl Phosphate (Phospha-E™) is able to lower biomarkers such as cholesterol and various inflammatory markers, compared with placebo, a capsule that looks the same as D-alpha Tocopheryl Phosphate (Phospha-E™) but has no active ingredient. These biomarkers are important factors that contribute to the development of metabolic syndrome It is not known whether D-alpha Tocopheryl Phosphate (Phospha-E™) is better than receiving no drug or receiving classical vitamin E, and this is what is to be determined. The study will compare two different doses of the study drug, D-alpha Tocopheryl Phosphate (Phospha-E™) to placebo (an inactive look alike capsule). It will also compare classical vitamin E to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27665 0
Address 27665 0
Country 27665 0
Phone 27665 0
Fax 27665 0
Email 27665 0
Contact person for public queries
Name 11040 0
Dr Esra Ogru
Address 11040 0
90 William Street
Melbourne VIC 3000
Country 11040 0
Australia
Phone 11040 0
(03) 9605 5900
Fax 11040 0
(03) 9605 5999
Email 11040 0
[email protected]
Contact person for scientific queries
Name 1968 0
Dr Roksan Libinaki
Address 1968 0
Building 13D
Wellington Road
Monash University
Melbourne VIC 3800
Country 1968 0
Australia
Phone 1968 0
(03) 9905 5325
Fax 1968 0
(03) 9905 9717
Email 1968 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
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