Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001026213
Ethics application status
Approved
Date submitted
23/11/2009
Date registered
26/11/2009
Date last updated
6/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of iodine supplementation on cognition in school-aged children
Scientific title
Randomized, double-blind, placebo-controlled trial investigating the effect of iodine supplementation on cognition in school-aged children
Secondary ID [1] 1143 0
Nil
Universal Trial Number (UTN)
Trial acronym
I-Learn Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iodine deficiency 252257 0
Condition category
Condition code
Diet and Nutrition 252446 252446 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A flavoured, chewable tablet containing 120 micrograms of iodine to be taken daily for 28 weeks
Intervention code [1] 241591 0
Prevention
Comparator / control treatment
A flavoured, chewable tablet containing placebo (identical to the active treatment with the exception of iodine content) to be taken daily for 28 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 253318 0
Cognitive performance will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [1] 253318 0
Baseline and post-intervention
Secondary outcome [1] 262391 0
Iodine status and thyroid status will be assessed by the measurement of urinary iodine concentrations, thyroglobulin, free thyroxine, and thyrotropin levels.
Timepoint [1] 262391 0
Baseline, 4 weeks after commencement of the intervention, and at post-intervention
Secondary outcome [2] 262397 0
Nutritional status will be assessed by a Food Frequency Questionnaire: The Australian Child and Adolescent Eating Survey
Timepoint [2] 262397 0
Baseline and post-intervention
Secondary outcome [3] 262398 0
Use of iodized or non-iodized salt at home will be assessed by a Type of Salt Used at Home Checklist
Timepoint [3] 262398 0
Baseline and post-intervention

Eligibility
Key inclusion criteria
Mildly iodine-deficient (i.e., a median urinary iodine concentration level of 50-99 micrograms per litre in the study population)
No history of thyroid disease
Not taking iodine-containing supplements
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of thyroid disease;
Taking iodine-containing supplements

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)
The iodine and placebo tablets will be provided by the supplier in bottles labelled with code numbers using NQuery software. The research group will remain blinded to which experimental condition participants are allocated until the end of the study when the code will be broken
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to receive bottles labelled with code numbers containing either iodine or placebo tablets using a random sequence generated by the RAND function in Microsoft 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
Recruiting
Date of first participant enrolment
Anticipated
3/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2261 0
5112

Funding & Sponsors
Funding source category [1] 244070 0
Charities/Societies/Foundations
Name [1] 244070 0
Pollin Prize for Paediatric Research
Country [1] 244070 0
United States of America
Primary sponsor type
University
Name
University of Adelaide
Address
Robinson Institute
School of Paediatrics and Reproductive Health
Medical North Building, Level 6
University of Adelaide
Frome Road
ADELAIDE SA 5005
Country
Australia
Secondary sponsor category [1] 251417 0
University
Name [1] 251417 0
University of Adelaide
Address [1] 251417 0
School of Psychology
Hughes Building, Level 4
University of Adelaide
North Terrace
ADELAIDE SA 5005
Country [1] 251417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258170 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 258170 0
The University of Adelaide
SA 5005
Ethics committee country [1] 258170 0
Australia
Date submitted for ethics approval [1] 258170 0
11/11/2009
Approval date [1] 258170 0
17/02/2010
Ethics approval number [1] 258170 0
H-177-2009
Ethics committee name [2] 258922 0
Government of South Australia
Department of Education and Children's Services
Ethics committee address [2] 258922 0
Policy Directorate
Education Centre
Level 8/31 Flinders Street
Adelaide SA 5000
Ethics committee country [2] 258922 0
Australia
Date submitted for ethics approval [2] 258922 0
03/03/2010
Approval date [2] 258922 0
29/04/2010
Ethics approval number [2] 258922 0
DECS CS/10/250.3

Summary
Brief summary
The study aims to examine the effect of iodine supplementation on cognition in mildly iodine-deficient school-aged children

The research hypothesis is that the cognitive test scores of children taking a daily iodine supplement will improve relative to baseline performance and compared to children taking a daily placebo over the 28-week trial period
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30540 0
Address 30540 0
Country 30540 0
Phone 30540 0
Fax 30540 0
Email 30540 0
Contact person for public queries
Name 13787 0
Associate Professor Vicki Clifton
Address 13787 0
Robinson Institute
Lyell McEwin Hospital
Haydown Road Elizabeth Vale SA 5112
Australia
Country 13787 0
Australia
Phone 13787 0
+61 8 8133 2133
Fax 13787 0
+61 8 8182 9337
Email 13787 0
[email protected]
Contact person for scientific queries
Name 4715 0
Associate Professor Vicki Clifton
Address 4715 0
Robinson Institute
Lyell McEwin Hospital
Haydown Road Elizabeth Vale SA 5112
Australia
Country 4715 0
Australia
Phone 4715 0
+61 8 8133 2133
Fax 4715 0
+61 8 8182 9337
Email 4715 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.