Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001106123
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Date results provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising selenium intake for cancer prevention - a pilot study in Auckland.
Scientific title
Supplementation of 200 micro grams/d selenium as selenized yeast for six months in a male cohort from Auckland, New Zealand to be monitored with biomarker variation with and without genetic stratification.
Secondary ID [1] 298727 0
Cancer Society New Zealand Grant No:. 06/06
Secondary ID [2] 298807 0
Cancer Society New Zealand Grant No: 10/08
Universal Trial Number (UTN)
U1111-1236-9311
Trial acronym
Linked study record
This study is linked to a follow up study extension approved by the NZ ethics committee ref. 18/NTB/134.
We are currently working on the ANZCTR registration for the extension study and once registration is complete, we will provide the registration ID. We have obtained a Universal Trial Number for this study which is U1111-1237-5893.

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer prevention 313647 0
Condition category
Condition code
Cancer 312068 312068 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optimising selenium intake for cancer prevention - a pilot study in Auckland.
This study employed a non-randomise supplementation with 200 micrograms selenium/day for six months as selenized yeast, provided by Alltech, Ireland in a capsulated form. One capsule contained one days dosage. Supplements were provided in 2 x three month batches. Participants were informed to contact the study centre for any queries as well as reporting of any unusual event during the study protocol including side effects. Participants were requested to stop supplementation if they notice any physical or emotional changes during supplementation until they check and clarify with the study centre. If significant side effects were noted, participants were requested to stop continuation of supplementation. Participants were also required to inform the study centre with regards to compliance and any noticeable side effects at the 11th week. The second batch of tablets were posted only after verifying the compliance and any side effects thus reported. Participants were to present the second compliance and noticeable side effects records at the end of the 24th week, when they visit the study centre for the post-supplementation visit.
Supplements were provided to the study participants by the study coordinator Dr. Nishi Karunasinghe under the guidance of Prof. Lynnette R Ferguson (the study PI who is also a Registered nutritionist with the New Zealand Nutrition Society (Scientific research) since 2001). Supplementation took place was at individual participant's home.
Intervention code [1] 314988 0
Prevention
Comparator / control treatment
This is a non-randomised intervention with no control group and the testing was done between pre- and post-supplementation.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320700 0
DNA damage modulation by selenium supplementation as uncontrolled DNA damage can be a precursor for cancer. DNA damage was assessed using Comet Assay protocol using leukocytes. Each subjects DNA damage was considered using a total quantitation of 50 leukocyte based comet like structures quantified using a fluorescence microscope system, and a specialized quantitation software.
Timepoint [1] 320700 0
Baseline and after 6 months supplementation.
Primary outcome [2] 320702 0
Selenium supplementation effects on seleno enzyme glutathione peroxidase activity. These were measured as any cancer including prostate cancer has an element of oxidative stress associated with disease pathways. Measurements were made in hemolysates using a kinetic spectrophotometric protocol where the amount of 1 µmol NADPH oxidized/min at 37°C by 1mg hemoglobin was considered as the GPx activity.
Timepoint [2] 320702 0
Baseline and after 6 months supplementation.
Primary outcome [3] 320804 0
Selenium supplementation effects on seleno enzyme thioredoxin reductase activity. These were measured as any cancer including prostate cancer has an element of oxidative stress associated with disease pathways. Measurements were made in hemolysates using a kinetic spectrophotometric protocol where the amount of 1 µmol 5-thio-2-nitrobenzoic acid formed/min at 37°C per 1mg hemoglobin was considered as the TR activity.
Timepoint [3] 320804 0
Baseline and after 6 months supplementation.
Secondary outcome [1] 372567 0
Se supplementation-related Caspase-cleaved K18 levels in plasma in extremes of H2O2 induced DNA damage subgroups (A subgroup of 19 men that showed the highest increase in H2O2-induced DNA damage after supplementation and a subgroup of 19 men that showed the highest decrease in H2O2-induced DNA damage after supplementation.
Timepoint [1] 372567 0
Baseline and after 6 months supplementation.
Secondary outcome [2] 372568 0
This is a composite secondary outcome. Impacts of selenium supplementation on prostate microarchitecture integritty measured by the serum levels of prostate-specific antigen levels with and without genetic and dietary interaction. Genetic interaction was studied using stratifications and analysis of PSA level between the homozygous dominant, heterozygous and homozygous recessive genotypes. Dietary interactions were studied using stratifications and analysis of PSA levels based on below or above dietary RDI levels or below or above the median dietary factor.
Please note that the dietary data were collected using a four day diary that recorded diet and activity level. These data was submitted to the FoodWorks Professional database (Xyris Software) and data were extracted from FoodWorks Professional 9 software.
Timepoint [2] 372568 0
Baseline and after 6 month supplementation.

Eligibility
Key inclusion criteria
Caucasian males in the age range 20-80y with no known cancers except for non-melanoma skin cancers, and not taking any dietary supplements containing >50 micrograms of selenium; (inherent serum selenium <200ng/ml added after recruitment), residents within the Auckland region, willing to attend the study centre based at the Faculty of Medical and Health Sciences, University of Auckland; willing to complete study questionnaires and keeping diet and activity diaries for four consecutive days.
Minimum age
20 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men taking any dietary supplements containing >50 micrograms of selenium.
With cancers excluding non-melanoma skin cancers
Men living outside Auckland region
Non-Caucasians.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Relationships between serum Se and biomarkers with and without stratification for genotypes were examined using Pearson's correlation statistics for simple correlations. Multiple regression analyses were carried out using generalised linear models (GLM), using the GLM procedure in SAS. Whether the relationship between the outcome and the predictor of serum Se concentration was linear was tested by fitting a quadratic polynomial. The GPx1 rs1050450 C/C and GPx4 rs713041 T/T genotypes show significant nonlinearity, so a ‘broken stick’ regression was fitted, with different linear regression models in two different regions constrained so that the fitted curve was continuous at the break point concentration. The optimal break point was chosen by taking the concentration which gave rise to the lowest RSS (Residual Sum of Squares). Variations between baseline and post-supplementation data for variables were compared using the Wilcoxon signed rank test with pooled ranks from both time points.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/10/2006
Date of last participant enrolment
Anticipated
Actual
22/12/2008
Date of last data collection
Anticipated
Actual
15/09/2014
Sample size
Target
600
Accrual to date
Final
571
Recruitment outside Australia
Country [1] 21681 0
New Zealand
State/province [1] 21681 0
Auckland

Funding & Sponsors
Funding source category [1] 303280 0
Charities/Societies/Foundations
Name [1] 303280 0
Cancer Society New Zealand
Country [1] 303280 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Faculty of Medical and Health Sciences,
University of Auckland
85, Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303301 0
Charities/Societies/Foundations
Name [1] 303301 0
Auckland Cancer Society Research Centre
Address [1] 303301 0
Faculty of Medical and Health Sciences
University of Auckland
85, Park Road
Grafton
Auckland 1023
Country [1] 303301 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303817 0
Northern Y Ethics Committee
Ethics committee address [1] 303817 0
Ethics committee country [1] 303817 0
New Zealand
Date submitted for ethics approval [1] 303817 0
14/10/2005
Approval date [1] 303817 0
25/09/2006
Ethics approval number [1] 303817 0
NTY/06/07/060

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

Contacts
Principal investigator
Name 94914 0
Prof Lynnette R Ferguson
Address 94914 0
Auckland Cancer Society Research Centre
Faculty of Medical and Health Sciences
University of Auckland
85, Park Road
Grafton
Auckland 1023
Country 94914 0
New Zealand
Phone 94914 0
+6493737599
Fax 94914 0
Email 94914 0
l.ferguson@auckland.ac.nz
Contact person for public queries
Name 94915 0
Nishi Karunasinghe
Address 94915 0
Auckland Cancer Society Research Centre
Faculty of Medical and Health Sciences
University of Auckland
85, Park Road
Grafton
Auckland 1023
Country 94915 0
New Zealand
Phone 94915 0
+6499234609
Fax 94915 0
Email 94915 0
n.karunasinghe@auckland.ac.nz
Contact person for scientific queries
Name 94916 0
Nishi Karunasinghe
Address 94916 0
Auckland Cancer Society Research Centre
Faculty of Medical and Health Sciences
University of Auckland
85, Park Road
Grafton
Auckland 1023
Country 94916 0
New Zealand
Phone 94916 0
+6499234609
Fax 94916 0
Email 94916 0
n.karunasinghe@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data related to published articles will be available as supplementary data tables as requested by scientific journals. Data will be used for comparison of features between New Zealand prostate cancer cohorts with this group as the control. Additionally, participant data both available and newly acquired may be used in Scientific Consortia we will get involved in.
When will data be available (start and end dates)?
Data on previously published articles will be available until end of 2021. For the next publications arising from the study, data will be available within five years of publication date.
Additionally, when ever the Scientific Consortia that we will be involved in, requires data sharing, they will be shared for comparison purposes of collaborators data.
Available to whom?
Available to anyone reading the published articles with supplementary data tables.
Data will also be available to the Scientific Consortia as mentioned above.
Available for what types of analyses?
Depends on the readers requirement such as cross checks.
For consortia work, it will be for comparisons between prostate cancer case-control cohorts from collaborating groups as well as Selenium supplementation-related studies.
How or where can data be obtained?
Depends on who and when data is required. If data is already given in supplementary tables, readers can access them directly. If not they can contact
Dr. Nishi Karunasinghe,
Research Fellow, Auckland Cancer Society Research Centre
University of Auckland
Private bag 92019
Auckland 1142
New Zealand
Phone: +64 9 923 4609
n.karunasinghe@auckland.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3040Ethical approvalOptimising selenium intake for cancer prevention – a pilot study in Auckland.. Investigators: Prof Lynnette R Ferguson (PI), Dr Martin Philpott, Dr Nishi Karunasinghe, Dr Jonathan Masters, Dr Nicole C Roy, Dr Sharon Browning, Prof Gil Hardy. Ethics ref: NTY/06/07/060 Locations: University of Auckland, Auckland Hospital, CMDHB. The above study has been given ethical approval by the Northern Y Regional Ethics Committee on the 15.09.2006. Approved Documents -Participant Information Sheet, version 2 dated 07 September 2006. -Consent Form, version 2 dated 11 September 2006  n.karunasinghe@auckland.ac.nz Original Ethical approval of this study can be obt... [More Details] 377964-(Uploaded-24-07-2019-11-39-14)-Study-related document.doc
3041Ethical approvalThis is the ethics communication on the conclusion of the current study. n.karunasinghe@auckland.ac.nz This is the ethics communication on the conclusion... [More Details] 377964-(Uploaded-31-07-2019-11-57-33)-Study-related document.docx
3042Study protocolResearch design for the original selenium supplementation study. The inclusion criteria for participant age was later amended to be between 20-80y. Ethics communication with regards to this amendment is therefore attached. n.karunasinghe@auckland.ac.nz Research design for the original selenium suppleme... [More Details] 377964-(Uploaded-31-07-2019-12-15-52)-Study-related document.docx
3650Ethical approval  n.karunasinghe@auckland.ac.nz Ethics amendments for the extension of recruitment... [More Details] 377964-(Uploaded-31-07-2019-12-01-19)-Study-related document.pdf
3839Informed consent form  n.karunasinghe@auckland.ac.nz Combined Information sheet and consent form can al... [More Details] 377964-(Uploaded-07-08-2019-09-40-14)-Study-related document.doc



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.