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Trial registered on ANZCTR


Trial ID
ACTRN12605000303640
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
6/09/2005
Date last updated
6/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose response study of phytosterols in tablet dosage in adults with primary hypercholeterolemia
Scientific title
Randomised, four arm, double blind placebo controlled dose response study of phytosterols in tablet dosage in adults with primary hypercholesterolemia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary hypercholesterolemia 391 0
Condition category
Condition code
Diet and Nutrition 463 463 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study compared baseline levels of lipids with post-treatment lipid levels for placebo and three concentrations of phytosterols(900mg/day or 1800mg/day or 2700mg/day) following 12 weeks of treatment.
Intervention code [1] 293 0
Treatment: Other
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 524 0
Change in LDL cholesterol from baseline to end of treatment.
Timepoint [1] 524 0
At baseline and at end of treatment
Secondary outcome [1] 1125 0
Changes in total cholesterol
Timepoint [1] 1125 0
Following 12 weeks of treatment.
Secondary outcome [2] 1126 0
Changes in high density lipoprotein cholesterol and triglycerides
Timepoint [2] 1126 0
Following 12 weeks of treatment.

Eligibility
Key inclusion criteria
1) LDL cholesterol greater then or equal to 3.5mmol/L and less than or equal to 5.7 mmol/L 2) Body mass index less than or equal to 32kg/m2
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Triglyceride levels greater then 4mmol/L2) Total cholesterol greater than 10mmol/L3) Use of lipid lowering medications including herbal and other "natural" lipid lowering agents with one month of baseline4) Clinically abnormal liver function tests at baseline5) Pregnant or women unwilling to use birth control for the period of the study6) Diabetes7) Hypothyroidism8) Smokers9) Cardiovascular disease10) Subjects unwilling to comply with study protocol11) Poor venous access12) Any other condition which in the opinion of the investigators could compromise the study.

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)
Study medications were supplied in numbered containers by the sponsor
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation scheme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Four-armed trial
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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] 518 0
Commercial sector/Industry
Name [1] 518 0
Mayne Health Consumer Products
Address [1] 518 0
Country [1] 518 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mayne Health Consumer Products
Address
Country
Australia
Secondary sponsor category [1] 422 0
None
Name [1] 422 0
NA
Address [1] 422 0
Country [1] 422 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35620 0
Address 35620 0
Country 35620 0
Phone 35620 0
Fax 35620 0
Email 35620 0
Contact person for public queries
Name 9482 0
Dr Phillip Cheras
Address 9482 0
Mater Health Services
Level 2 Community Services Building
South Brisbane QLD 4101
Country 9482 0
Australia
Phone 9482 0
+61 7 38406120
Fax 9482 0
+61 7 38406119
Email 9482 0
p.cheras@uq.edu.au
Contact person for scientific queries
Name 410 0
Dr Phillip Cheras
Address 410 0
Mater Health Services
Level 2 Community Services Building
South Brisbane QLD 4101
Country 410 0
Australia
Phone 410 0
+61 7 38406120
Fax 410 0
+61 7 38406119
Email 410 0
p.cheras@uq.edu.au