Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000789763
Ethics application status
Approved
Date submitted
20/06/2013
Date registered
15/07/2013
Date last updated
9/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Study on Adults and Iodine Deficiency (SAID)
Scientific title
A randomised, double-blind, placebo-controlled intervention trial of the effect of iodine supplementation on thyroglobulin concentration in mildly iodine deficient young adults
Secondary ID [1] 282711 0
Nil
Universal Trial Number (UTN)
U1111-1144-8095
Trial acronym
Study on Adults and Iodine Deficiency (SAID)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Iodine Deficiency 289425 0
Condition category
Condition code
Diet and Nutrition 289758 289758 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral iodine supplement (150 mcg Iodine/day) for 6 months. Tablets will be supplied in a 28 day blister pack/month; blister packs will be returned and remaining tablets measured to monitor adherance.
Intervention code [1] 287372 0
Treatment: Other
Comparator / control treatment
Placebo supplement (0 mcg Iodine/day) for 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 289839 0
Change in serum thyroglobulin concentration measured by assay.
Timepoint [1] 289839 0
6 months
Secondary outcome [1] 303358 0
Change in urinary iodine concentration
Timepoint [1] 303358 0
6 months

Eligibility
Key inclusion criteria
Healthy, free of thyroid disease, eats 2 or less servings of commercial bread/day, not taking iodine supplements, not pregnant or planning a pregnancy, not breastfeeding, with urinary iodine concentration less than 100 mcg/L.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Urinary Iodine Concentration >100 mcg/L
Presence of thyroid antibodies
Low T4 or High TSH

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)
Recruitment by advertisement.
Randomisation will be planned and generated by a researched not directly involved in participant recruitment or data collection. Allocation will be concealed by sealed opaque numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
RAND on Excel in blocks stratified for sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined using STATA based on difference of 4 mcg/L at the end of the intervention between supplemented and placebo groups.
Regression Analysis, Mixed Models

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
Actual
9/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
112
Recruitment outside Australia
Country [1] 5157 0
New Zealand
State/province [1] 5157 0

Funding & Sponsors
Funding source category [1] 287481 0
Charities/Societies/Foundations
Name [1] 287481 0
Laurenson Fund
Country [1] 287481 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 286223 0
None
Name [1] 286223 0
Address [1] 286223 0
Country [1] 286223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289459 0
University of Otago Ethics Committee
Ethics committee address [1] 289459 0
Academic Services
University of Otago
PO Box 56
Dunedin
9054
Ethics committee country [1] 289459 0
New Zealand
Date submitted for ethics approval [1] 289459 0
Approval date [1] 289459 0
19/03/2013
Ethics approval number [1] 289459 0
13/059

Summary
Brief summary
The aim of this study is to determine the efficacy of thyroglobulin concentration in assessing iodine status in individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40938 0
Dr Sheila A Skeaff
Address 40938 0
Dept Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 40938 0
New Zealand
Phone 40938 0
+643 479 7944
Fax 40938 0
+643 479 7958
Email 40938 0
sheila.skeaff@otago.ac.nz
Contact person for public queries
Name 40939 0
Dr Sheila A Skeaff
Address 40939 0
Dept Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 40939 0
New Zealand
Phone 40939 0
+643 479 7944
Fax 40939 0
+643 479 7958
Email 40939 0
sheila.skeaff@otago.ac.nz
Contact person for scientific queries
Name 40940 0
Dr Sheila A Skeaff
Address 40940 0
Dept Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 40940 0
New Zealand
Phone 40940 0
+643 479 7944
Fax 40940 0
+643 479 7958
Email 40940 0
sheila.skeaff@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
SourceTitleYear of PublicationDOI
EmbaseIodine supplementation of mildly iodine-deficient adults lowers thyroglobulin: A randomized controlled trial.2016https://dx.doi.org/10.1210/jc.2015-3591
N.B. These documents automatically identified may not have been verified by the study sponsor.