Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000519055
Ethics application status
Approved
Date submitted
22/06/2010
Date registered
23/06/2010
Date last updated
14/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of iodine supplementation on cognition and well-being in mildly deficient young adults
Scientific title
A randomised controlled trial to determine the effect of iodine supplementation on cognition and well-being in mildly deficient young adults
Secondary ID [1] 252081 0
Nil
Universal Trial Number (UTN)
U1111-1115-5764
Trial acronym
THINK2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition, well-being and iodine status 257627 0
Condition category
Condition code
Diet and Nutrition 257800 257800 0 0
Other diet and nutrition disorders
Mental Health 257808 257808 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
150 micrograms of iodine/day orally for 32 weeks
Intervention code [1] 256705 0
Treatment: Other
Comparator / control treatment
placebo (eg sugar pill identical to intervention exposure)/day orally for 36 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 258668 0
Cognition as measured by subtests of the Weschler Adult Intelligence Scales.
Timepoint [1] 258668 0
Baseline and 32 weeks
Secondary outcome [1] 264646 0
Well-being as measured by Short-Form 36 (SF-36).
Timepoint [1] 264646 0
Baseline and 32 weeks
Secondary outcome [2] 264647 0
Iodine status as measured by urinary iodine concentration, and thyroglobulin
Timepoint [2] 264647 0
Baseline and 32 weeks

Eligibility
Key inclusion criteria
18-30 years
healthy
free of thyroid disease
not pregnant
not taking iodine containing supplements
mildly iodine deficient
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Eats more than 2 servings of commercial bread products a day.

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)
Subject randomly allocated to placebo or treatment. Treatment and placebo tablets are identical and given letter code by third party not involved in research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using the RAND function in Excel.
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
Completed
Date of first participant enrolment
Anticipated
5/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2709 0
New Zealand
State/province [1] 2709 0
Otago

Funding & Sponsors
Funding source category [1] 257174 0
University
Name [1] 257174 0
Dept Human Nutrition, University of Otago
Country [1] 257174 0
New Zealand
Funding source category [2] 257175 0
Charities/Societies/Foundations
Name [2] 257175 0
Maurice and Phyllis Paykel Trust
Country [2] 257175 0
New Zealand
Primary sponsor type
University
Name
Dept Human Nutrition, University of Otago
Address
PO Box 56, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 256433 0
Charities/Societies/Foundations
Name [1] 256433 0
Maurice and Phyllis Paykel Trust
Address [1] 256433 0
PO Box 37760
Parnell, Auckland 1151
Country [1] 256433 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259214 0
University of Otago Ethics Committee
Ethics committee address [1] 259214 0
Ethics committee country [1] 259214 0
New Zealand
Date submitted for ethics approval [1] 259214 0
Approval date [1] 259214 0
01/06/2010
Ethics approval number [1] 259214 0
1/10/0026

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

Contacts
Principal investigator
Name 31324 0
Address 31324 0
Country 31324 0
Phone 31324 0
Fax 31324 0
Email 31324 0
Contact person for public queries
Name 14571 0
Dr Sheila Skeaff
Address 14571 0
Dept Human Nutrition
University of Otago
PO Box 56
Dunedin, 9054
Country 14571 0
New Zealand
Phone 14571 0
+643-479-7944
Fax 14571 0
+643-479-7958
Email 14571 0
[email protected]
Contact person for scientific queries
Name 5499 0
Dr Sheila Skeaff
Address 5499 0
Dept Human Nutrition
University of Otago
PO Box 56
Dunedin, 9054
Country 5499 0
New Zealand
Phone 5499 0
+643-479-7944
Fax 5499 0
+643-479-7958
Email 5499 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.