Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000651482
Ethics application status
Approved
Date submitted
24/10/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutritional polypill trial in well subjects in order to assess genome damage
Scientific title
A polypill vs placebo trial to assess genome damage in well subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Damage in lymphocyte deoxyribonucleic acid (DNA) 2503 0
Condition category
Condition code
Diet and Nutrition 2599 2599 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 2 small tablets + 1 capsule, taken simultaneously, daily, orally; Contents: vitamins (B12, E, A, B3) and essential nutrients (folate, calcium); Duration: 16 weeks;
Exposure: lifestyle, ageing, nutrition practices.
Intervention code [1] 2231 0
Prevention
Comparator / control treatment
2 small tablets + 1 capsule, tablets and capsule taken daily (sugar pills).
Control group
Placebo

Outcomes
Primary outcome [1] 3509 0
Micronucleus (MN) frequency in lymphocytes assessed by visual scoring.
Timepoint [1] 3509 0
3 x 16 week phases with active & placebo interventions ocurring in 2nd and 3rd phases
Secondary outcome [1] 5858 0
Global methylation of DNA and CpG island (DNA stretch where higher frequency of C-G pairs is observed).
Timepoint [1] 5858 0
16, 32 and 48 weeks

Eligibility
Key inclusion criteria
25 - 45 year-old healthy males and females.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who smoke, are currently being treated with anti-folate drugs, are planning a pregnancy or are currently pregnant, are unable to participate in all phases of the trial, or are supplementing their diet with more than 50% of the recommended daily dietary allowance (RDA) of any nutrients identified for the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment codes generated by independent allocation; only subject and bottle numbers are available at registration; dispensing bottles and contents are identical in apprearance for both treatment and active groups;
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment sequence was generated by stratified (tertiles of age, sex of volunteers obtained from phase 1), randomised blocks of size 4, with each block containing 2 placebo and two active treatment allocations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 306 0
5000

Funding & Sponsors
Funding source category [1] 2748 0
Government body
Name [1] 2748 0
National Health and Medical Research Council (NHMRC)
Country [1] 2748 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Canberra ACT
Country
Australia
Secondary sponsor category [1] 2483 0
Government body
Name [1] 2483 0
NHMRC
Address [1] 2483 0
Canberra ACT
Country [1] 2483 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4827 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 4827 0
Ethics committee country [1] 4827 0
Australia
Date submitted for ethics approval [1] 4827 0
Approval date [1] 4827 0
28/05/2007
Ethics approval number [1] 4827 0

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

Contacts
Principal investigator
Name 28143 0
Address 28143 0
Country 28143 0
Phone 28143 0
Fax 28143 0
Email 28143 0
Contact person for public queries
Name 11300 0
Professor Bruce Armstrong
Address 11300 0
Sydney Cancer Centre
Gloucester House
Royal Prince Alfred Hospital
Sydney NSW
Country 11300 0
Australia
Phone 11300 0
+61 2 95157069
Fax 11300 0
Email 11300 0
[email protected]
Contact person for scientific queries
Name 2228 0
Professor Bruce Armstrong
Address 2228 0
Sydney Cancer Centre
Gloucester House
Royal Prince Alfred Hospital
Sydney NSW
Country 2228 0
Australia
Phone 2228 0
+61 2 95157069
Fax 2228 0
Email 2228 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.