Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000368639
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of iodine and selenium intervention on the thyroid status of older New Zealanders
Scientific title
Effect of iodine and selenium intervention on the thyroid status of older New Zealanders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Selenium, Iodine and Thyroid Status 463 0
Condition category
Condition code
Metabolic and Endocrine 540 540 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of four treatment groups & given a supplement containing either; selenium, iodine, selenium & iodine or placebo. Participants take one supplement daily for 12 weeks. Selenium, iodine and thryoid status of participants will be measured at 5 time point over the intervention.
Intervention code [1] 227 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 631 0
To determine the effects of a 12 week supplementation with iodine and selenium on thyroid status
Timepoint [1] 631 0
Secondary outcome [1] 1304 0
To investigate interactions between selenium and thyroid status
Timepoint [1] 1304 0
At 5 time points over a 12 week period.
Secondary outcome [2] 1305 0
To determine the effects of iodine supplementation, with or without selenium, on throid metabolism as measured by the ratio of the active hormone T3 to the inactive hormone T4.
Timepoint [2] 1305 0
At 5 time points over a 12 week period.

Eligibility
Key inclusion criteria
Plasma Selenium <100ugLPersons not institutionalisedAmbulatoryGood Health with no serious medical illnesses
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Institutionalised. Plasma Se >100ugL. Serious Medical Illness

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)
A statistician randomly allocated participants to one of the four groups (A, B, C or D). Participants will be given a tablet bottle containing either tablets A, B, C or D, none of the researchers conducting the study know what supplement type each letter signifies-One person within our department holds the 'code breaker' for the study which tells us what supplement type each letter corresponds to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Statistician used block randomisation & computer software to generate the random allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 143 0
New Zealand
State/province [1] 143 0

Funding & Sponsors
Funding source category [1] 598 0
Charities/Societies/Foundations
Name [1] 598 0
University Melb.Dept. Gen Practice
Country [1] 598 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Dunedin, New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 487 0
None
Name [1] 487 0
nil
Address [1] 487 0
Country [1] 487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1696 0
University of Otago Human Ethics Committee
Ethics committee address [1] 1696 0
Ethics committee country [1] 1696 0
New Zealand
Date submitted for ethics approval [1] 1696 0
Approval date [1] 1696 0
Ethics approval number [1] 1696 0

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

Contacts
Principal investigator
Name 35629 0
Address 35629 0
Country 35629 0
Phone 35629 0
Fax 35629 0
Email 35629 0
Contact person for public queries
Name 9416 0
Jenny Campbell
Address 9416 0
C/- Department of Human Nutrition University of Otago
Union St
PO Box 56
Dunedin 9007
Country 9416 0
New Zealand
Phone 9416 0
+64 3 4795673
Fax 9416 0
Email 9416 0
camje266@student.otago.ac.nz
Contact person for scientific queries
Name 344 0
Associate Professor Christine Thomson
Address 344 0
C/- Department of Human Nutrition University of Otago
Union St
PO Box 56
Dunedin 9007
Country 344 0
New Zealand
Phone 344 0
+64 3 4797943
Fax 344 0
Email 344 0
christine.thomson@stonebow.otago.ac.nz

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.