Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001200774
Ethics application status
Approved
Date submitted
18/10/2013
Date registered
31/10/2013
Date last updated
12/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Zinc Supplementation on Expression of Zinc Transporters in Healthy Individuals
Scientific title
The Effect of Zinc Supplementation on Expression of Zinc Transporters in Healthy Individuals
Secondary ID [1] 283415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Zinc transport 290327 0
Condition category
Condition code
Diet and Nutrition 290729 290729 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zinc Chelate 220mg (22mg elemental zinc), one tablet per day for 21 days administered orally (TGA registry - ARTG 128690). Compliance will be checked by tablet return and plasma zinc levels.
Intervention code [1] 288138 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 290727 0
Zinc transporter mRNA expression in peripheral blood mononuclear cells by real-time quantitative PCR
Timepoint [1] 290727 0
22 days
Primary outcome [2] 290728 0
Inflammation (CRP, IL-1, IL6, TNF-alpha) by rate nephelometry or similar
Timepoint [2] 290728 0
22 days
Secondary outcome [1] 305103 0
Plasma zinc by ICP-MS
Timepoint [1] 305103 0
22 days

Eligibility
Key inclusion criteria
- Adults, age 18-65 y
- Have not been diagnosed with major illness
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diagnosis of major illness
- Taking of prescription drugs which known to interact with zinc
- Women who are pregnant or breastfeeding

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The sample size for this study is 40. There is no literature on zinc transporter expression under these intervention conditions. We feel a sample size of 40 is reasonable for a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
18/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288141 0
Other
Name [1] 288141 0
Meat and Livestock Australia
Country [1] 288141 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 286858 0
None
Name [1] 286858 0
Address [1] 286858 0
Country [1] 286858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290054 0
University of Sydney HREC
Ethics committee address [1] 290054 0
Level 2, Margaret Telfer
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 290054 0
Australia
Date submitted for ethics approval [1] 290054 0
10/09/2012
Approval date [1] 290054 0
04/08/2013
Ethics approval number [1] 290054 0
2012/370

Summary
Brief summary
Sub-groups of the Australian population are considered at risk of zinc deficiency but uncertainty remains
in the interpretation of zinc biomarkers. Zinc has no definable, accessible body stores. Our proposal aims
to explore the usefulness of zinc transporters, which regulate the movement of zinc into and within-cells,
as potential biomarkers of zinc status in humans. We aim to examine the feasibility of using peripheral blood mononuclear cells for the assessment of zinc status. If our
approach is successful we will have the potential of investigating zinc status in greater detail.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43722 0
A/Prof Samir Samman
Address 43722 0
Rm 475, Biochemistry Building G08
The University of Sydney
NSW 2006
Country 43722 0
Australia
Phone 43722 0
+61 2 9351 2476
Fax 43722 0
Email 43722 0
[email protected]
Contact person for public queries
Name 43723 0
A/Prof Samir Samman
Address 43723 0
Rm 475, Biochemistry Building G08
The University of Sydney
NSW 2006
Country 43723 0
Australia
Phone 43723 0
+61 2 9351 2476
Fax 43723 0
Email 43723 0
[email protected]
Contact person for scientific queries
Name 43724 0
A/Prof Samir Samman
Address 43724 0
Rm 475, Biochemistry Building G08
The University of Sydney
NSW 2006
Country 43724 0
Australia
Phone 43724 0
+61 2 9351 2476
Fax 43724 0
Email 43724 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
SourceTitleYear of PublicationDOI
EmbaseZinc-induced upregulation of metallothionein (MT)-2A is predicted by gene expression of zinc transporters in healthy adults.2015https://dx.doi.org/10.1007/s12263-015-0494-y
N.B. These documents automatically identified may not have been verified by the study sponsor.