Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000169044
Ethics application status
Approved
Date submitted
17/02/2010
Date registered
22/02/2010
Date last updated
7/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of CYP1A2 drug metabolism activity in Europeans and South Asians
Scientific title
Ethnic differences in Drug Metabolism: Investigation of CYP1A2 drug metabolism activity by testing caffeine in Europeans and South Asians
Secondary ID [1] 1426 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study is looking at ethnic differences in metabolic activity of CYP1A2 between people of European and South Asian Ancestry 256838 0
Condition category
Condition code
Metabolic and Endocrine 256986 256986 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single dose of caffeine (100 mg via NoDoz tablets available over the counter) will be administered to participants. Saliva samples will then be collected at 2 and 4 hours after the participant takes the caffeine dose to estimate CYP1A2 activity.

Recruitment will take place over a year between April 1/2010 and April 1/2011
Intervention code [1] 256037 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257875 0
Compare the CYP1A2 activity of South Asians and Europeans using the 4 h paraxanthine/caffeine concentration ratio in saliva
Timepoint [1] 257875 0
THe outcomes measured will be after recruitment which will take one year
Secondary outcome [1] 263330 0
Correlate the CYP1A2 activity of all subjects to CYP1A2 polymorphisms for the total cohort and after stratifying by ethnicity.

When stratifying groups into SOuth Asian and European, independent samples t-test will be used to assess differences. For more than two groups ANOVA will be used. Calculations will be conducted using excel 2003-2007 and Statistical Packages for the Social Sciences (SPSS) V 16.0
Timepoint [1] 263330 0
THe outcomes measured will be after recruitment which will take one year
Secondary outcome [2] 263331 0
Correlate dietary/lifestyle factors with CYP1A2 activity;

Linear regression will be used to assess factors which affect CYP1A2 activity. Calculations will be conducted using excel 2003-2007 and Statistical Packages for the Social Sciences (SPSS) V 16.0
Timepoint [2] 263331 0
THe outcomes measured will be after recruitment which will take one year

Eligibility
Key inclusion criteria
Only those people of European and South Asian ancestry can take part in this study. Ethnicity of a person will be assigned based on the ethnicity of a person’s four grandparents (i.e. all four grandparents need to be of the same ethnicity and have the same country of birth).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who will be excluded from the study include if they are
Under 18 years of age,
suffering from an acute illness (hospitalised),
pregnant or breast-feeding women, and
being too ill (or where illness compromises the ability to produce uncontaminated saliva (e.g. gum disease such as gingivitis)).
not able to understand English

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256539 0
University
Name [1] 256539 0
The University of Sydney
Country [1] 256539 0
Australia
Primary sponsor type
University
Name
THe University of Sydney
Address
Camperdown and Darlington Campuses
City Road
Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 255842 0
None
Name [1] 255842 0
Address [1] 255842 0
Country [1] 255842 0
Other collaborator category [1] 1124 0
Hospital
Name [1] 1124 0
Concord Hospital
Address [1] 1124 0
Building 4
Hospital Road
Concord Hospital
Concord NSW 2139
Country [1] 1124 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258582 0
Sydney South West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 258582 0
Building 75, Concord Hospital, Hospital Rd Concord, NSW 2139
Ethics committee country [1] 258582 0
Australia
Date submitted for ethics approval [1] 258582 0
16/02/2010
Approval date [1] 258582 0
Ethics approval number [1] 258582 0
Ethics committee name [2] 260565 0
Sydney South West Area Health Service Human Research Ethics Committee (Concord Repatriation General
Hospital Zone) (EC00118)
Ethics committee address [2] 260565 0
Building 4, Concord Hospital, Concord, NSW 2139
Ethics committee country [2] 260565 0
Australia
Date submitted for ethics approval [2] 260565 0
Approval date [2] 260565 0
05/05/2010
Ethics approval number [2] 260565 0
HREC/10/CRGH/24

Summary
Brief summary
The study found a significant difference in the median CYP1A2 activity in those of South Asian and European ancestry.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30856 0
Address 30856 0
Country 30856 0
Phone 30856 0
Fax 30856 0
Email 30856 0
Contact person for public queries
Name 14103 0
Andrew McLachlan
Address 14103 0
Centre for Education and Research on Ageing
Concord RG Hospital, Building 76, Concord NSW 2139
Country 14103 0
Australia
Phone 14103 0
+61 2 9767 7373
Fax 14103 0
Email 14103 0
andrew.mclachlan@sydney.edu.au
Contact person for scientific queries
Name 5031 0
Andrew McLachlan
Address 5031 0
Centre for Education and Research on Ageing
Concord RG Hospital, Building 76, Concord NSW 2139
Country 5031 0
Australia
Phone 5031 0
+61 2 9767 7373
Fax 5031 0
Email 5031 0
andrew.mclachlan@sydney.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
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Documents added automatically
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