Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000059066
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
19/01/2010
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Zinc and DNA Health
Scientific title
Effects of zinc supplementation on lymphocyte and buccal cell genome instability in an elderly Australian population
Secondary ID [1] 1294 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Zinc status in elderly population 256578 0
Condition category
Condition code
Diet and Nutrition 256744 256744 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will be given either zinc tablets -20mg/tablet or placebo tablets daily for 3 months. This supplement will be delivered orally in tablet form.
Subjects will have two separate visits to the CSIRO Clinic of 30 minutes duration each on day 0 and day 90, end of intervention. Following a baseline visit they will be randomised to consume a placebo or a 20 mg Zinc tablet for 3 months. The visits will 12 weeks apart. At each visit, volunteers will provide blood and buccal cell sample.
Intervention code [1] 255834 0
Lifestyle
Intervention code [2] 255852 0
Other interventions
Comparator / control treatment
Placebo tablets will be the control treatment and identical in appearance to the active tablets and only contain maltodextrin. Volunteers will be given either zinc tablets 20mg/tablet or placebo tablets daily for 3 months. This supplement will be delivered orally in tablet form.
Subjects will have two separate visits to the CSIRO Clinic of 30 minutes duration each on day 0 and day 90,end of intervention. Following a baseline visit they will be randomised to consume a placebo or a 20 mg Zinc tablet for 3 months. The visits will 12 weeks apart. At each visit, volunteers will provide blood and buccal cell sample.
Control group
Placebo

Outcomes
Primary outcome [1] 257632 0
Blood collected will be isolated for lymphocytes to provide a means of measurement for genetic damage. Deoxyribonucleic Acid (DNA) damage in lymphocytes can be assessed using Cytokinesis Block Micronucleus Cytome (CBMN-Cyt) assay which is a reliable and comprehensive method to evaluate DNA damage, cytostasis and cytotoxicity events in lymphocytes.
Timepoint [1] 257632 0
Day 0 baseline and day 90,end of intervention
Secondary outcome [1] 262904 0
We will utilize buccal cells as a non-invasive method to measure DNA damage by performing Buccal Micronucleus Cytome (BM-Cyt) assay. Buccal cells collected from consented participants will be used to prepare microscope slides to investigate genomic instability, cell proliferation and cell death parameters as previously described.
Timepoint [1] 262904 0
Day 0 baseline and day 90, end of intervention

Eligibility
Key inclusion criteria
Healthy men and women aged over 65 years
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals supplementing with more than 25% of the recommended dietary intake of zinc. Individuals with habitual dietary intake > 20 mg/day. Individuals undergoing radiotherapy/chemotherapy treatment for cancer. Individuals with plasma zinc > 10.5 micromoles

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256339 0
Government body
Name [1] 256339 0
Commonwealth Scientific Industrial Research Organization
Country [1] 256339 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organization
Address
Gate 13 Kintore Avenue 5000 Adelaide
SA
Country
Australia
Secondary sponsor category [1] 251653 0
None
Name [1] 251653 0
Address [1] 251653 0
Country [1] 251653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258407 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 258407 0
Ethics committee country [1] 258407 0
Australia
Date submitted for ethics approval [1] 258407 0
Approval date [1] 258407 0
24/09/2009
Ethics approval number [1] 258407 0
09/25
Ethics committee name [2] 258408 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 258408 0
Ethics committee country [2] 258408 0
Australia
Date submitted for ethics approval [2] 258408 0
Approval date [2] 258408 0
22/10/2009
Ethics approval number [2] 258408 0
H-150-2009

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

Contacts
Principal investigator
Name 30716 0
Address 30716 0
Country 30716 0
Phone 30716 0
Fax 30716 0
Email 30716 0
Contact person for public queries
Name 13963 0
Razinah Sharif
Address 13963 0
CSIRO Food and Nutritional Sciences.
Gate 13, Kintore Avenue, Adelaide
5000 SA
Country 13963 0
Australia
Phone 13963 0
+618 83050672
Fax 13963 0
Email 13963 0
razinah.sharif@csiro.au
Contact person for scientific queries
Name 4891 0
Dr Phil Thomas
Address 4891 0
CSIRO Food and Nutritional Sciences.
Gate 13, Kintore Avenue, Adelaide
5000 SA
Country 4891 0
Australia
Phone 4891 0
+618 8303 8897
Fax 4891 0
Email 4891 0
phil.thomas@csiro.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.