Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000222347
Ethics application status
Approved
Date submitted
17/04/2008
Date registered
24/04/2008
Date last updated
19/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy brains and iodine in kids
Scientific title
Randomised, double-blind, placebo-controlled intervention trial investigating the effect of iodine supplementation on cognition in school aged children
Universal Trial Number (UTN)
Trial acronym
think project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition and iodine status 3070 0
Condition category
Condition code
Diet and Nutrition 3224 3224 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
150 micrograms of iodine/day orally for 26 weeks
Intervention code [1] 2812 0
Treatment: Other
Comparator / control treatment
placebo eg sugar pill identical to treatment
Control group
Placebo

Outcomes
Primary outcome [1] 4107 0
Cognition as measured by subcomponents of Weschler Intelligence Scale for Children-FOurth Edition (WISC-IV)
Timepoint [1] 4107 0
baseline and 26 weeks
Secondary outcome [1] 6921 0
iodine status as measured by urinary iodine concenration, thyroglobulin and free T4
Timepoint [1] 6921 0
baseline and 26 weeks

Eligibility
Key inclusion criteria
10-12 years of age
healthy
no thyroid disease
not taking iodine-containing supplements
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
thyroid disease
taking iodine-containing supplements

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 (block) 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
262
Accrual to date
Final
Recruitment outside Australia
Country [1] 924 0
New Zealand
State/province [1] 924 0
Otago

Funding & Sponsors
Funding source category [1] 3316 0
Charities/Societies/Foundations
Name [1] 3316 0
Maurice and Phyllis Paykel Trust
Country [1] 3316 0
New Zealand
Funding source category [2] 3317 0
University
Name [2] 3317 0
University of Otago
Country [2] 3317 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
University of Otago
PO Box 56, Dunedin
Country
New Zealand
Secondary sponsor category [1] 2967 0
Charities/Societies/Foundations
Name [1] 2967 0
Maurice and Phyllis Paykel Trust
Address [1] 2967 0
(No Street address)
PO Box 37760
Parnell, Auckland
Country [1] 2967 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5301 0
University of Otago Ethics Committee
Ethics committee address [1] 5301 0
University of Otago
PO Box 56
Dunedin
Ethics committee country [1] 5301 0
New Zealand
Date submitted for ethics approval [1] 5301 0
09/01/2007
Approval date [1] 5301 0
27/06/2007
Ethics approval number [1] 5301 0
07/011

Summary
Brief summary
To determine if increased iodine intake improves cognition in mildly iodine deficient children
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28541 0
Address 28541 0
Country 28541 0
Phone 28541 0
Fax 28541 0
Email 28541 0
Contact person for public queries
Name 11698 0
Dr Sheila Skeaff
Address 11698 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 11698 0
New Zealand
Phone 11698 0
+643-479-7944
Fax 11698 0
+643-479-7958
Email 11698 0
[email protected]
Contact person for scientific queries
Name 2626 0
Dr Sheila Skeaff
Address 2626 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 2626 0
New Zealand
Phone 2626 0
+643-479-7944
Fax 2626 0
+643-479-7958
Email 2626 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
Dimensions AIIodine supplementation improves cognition in mildly iodine-deficient children2009https://doi.org/10.3945/ajcn.2009.28145
N.B. These documents automatically identified may not have been verified by the study sponsor.