Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001546145
Ethics application status
Approved
Date submitted
22/10/2019
Date registered
11/11/2019
Date last updated
11/11/2019
Date data sharing statement initially provided
11/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary iodine intake and urinary iodine concentration in vegan & plant-based and non-vegan or plant-based women of childbearing age of South Australia
Scientific title
Dietary iodine intake and urinary iodine concentration in vegan & plant-based and non-vegan or plant-based women of childbearing age of South Australia
Secondary ID [1] 299615 0
Nil known
Universal Trial Number (UTN)
U1111-1242-3786
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Dietary Iodine Intake 314908 0
Low Dietary Selenium Intake 314909 0
Condition category
Condition code
Diet and Nutrition 313263 313263 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross sectional pilot study including 50 pre-menopausal women, age 18-50. Recruitment will involve 25 vegan and 25 non vegan participants, which may include vegetarians. Participants will be asked to visit the clinical trials facility at the University of South Australia on two separate occasions to provide a spot urine sample as well as complete a diet record using an on-line diet analysis program over 2 days. dietary iodine and selenium intake between vegan and non vegan participants. Comparing urinary iodine concentration between the two groups.

Participants are required to complete questionnaires, provide urine samples for urinary iodine concentration testing. Fill out an online dietary application for 2 days.

(2 days dietary recording - research food diary application)
(2 separate days taking urinary iodine concentration - 2 tests in 2 weeks)
(2 further questionnaires (1 each week))
Intervention code [1] 315867 0
Diagnosis / Prognosis
Comparator / control treatment
Control group includes omnivores and vegetarians.
They will participate in the same activities as the vegan group.
- questionnaires, urinary iodine concentration, food diary recording for 2 days.
Control group
Active

Outcomes
Primary outcome [1] 321756 0
Urinary iodine concentration was assessed in those who consume plant based diets compared to the control group
Timepoint [1] 321756 0
Urine samples are collected on day 1 and day 8 or 9.
Secondary outcome [1] 376133 0
Describe dietary sources of iodine in both groups.
A questionnaire and a downloadable research food diary application on their phones will be used.
The questionnaire was designed specifically for this study.
Timepoint [1] 376133 0
The two days of food diary will be recorded on any two days between visit one and two (the two visits will be one week apart)

Eligibility
Key inclusion criteria
18-50 year old pre menopausal females.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infertility. Pregnant. Breastfeeding,

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis
Research food diary app to collect dietary information. Urinary iodine concentration obtained.
SPSS to describe the iodine excretion and intake of the participants using box plots and histograms. P<0.05 will be considered statistically significant. Normally distributed data will be presented as a mean with a standard deviation and non-normally distributed information will be presented as a median with 95% confidence intervals. The groups will be compared using unpaired t-tests if normally distributed or non-parametric (Mann-Whitney) tests if not normally distributed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/11/2019
Date of last participant enrolment
Anticipated
15/01/2020
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15029 0
UniSA Health and Medical Clinic (City West) - Adelaide
Recruitment postcode(s) [1] 28315 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304092 0
University
Name [1] 304092 0
University of South Australia
Country [1] 304092 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
UNISA, City East Campus,
Frome Road, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 304301 0
None
Name [1] 304301 0
Address [1] 304301 0
Country [1] 304301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304581 0
UNISA Human Research Ethics Committee
Ethics committee address [1] 304581 0
University of South Australia | Mawson Lakes Campus | Mawson Lakes SA 5095
GPO Box 2471 | Adelaide | South Australia 5001
Ethics committee country [1] 304581 0
Australia
Date submitted for ethics approval [1] 304581 0
16/05/2019
Approval date [1] 304581 0
15/10/2019
Ethics approval number [1] 304581 0
202118

Summary
Brief summary
Several studies have been completed in countries other than Australia comparing urinary iodine concentration and iodine intake in omnivores, vegetarians and vegans. It has been found that plant based diets are lower in iodine in these studies. Dairy is one of the first or second main sources of iodine in the Australian diet, while it is variable depending on geographic location and supplementary feeding practices. Plant milks are currently low in iodine and are subject to fortification restrictions in Australia. The research may help to update fortification guidelines for plant based products. The hypothesis is that the plant based group will have a lower urinary concentration of iodine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97466 0
Ms Jane Whitbread
Address 97466 0
UNISA - City East Campus,
Frome Road, Adelaide.
SA, 5000
Country 97466 0
Australia
Phone 97466 0
+61 8 830 22579
Fax 97466 0
Email 97466 0
[email protected]
Contact person for public queries
Name 97467 0
Ms Jane Whitbread
Address 97467 0
UNISA - City East Campus,
Frome Road, Adelaide.
SA, 5000
Country 97467 0
Australia
Phone 97467 0
+61 8 830 22579
Fax 97467 0
Email 97467 0
[email protected]
Contact person for scientific queries
Name 97468 0
Ms Jane Whitbread
Address 97468 0
UNISA - City East Campus,
Frome Road, Adelaide.
SA, 5000
Country 97468 0
Australia
Phone 97468 0
+61 8 830 22579
Fax 97468 0
Email 97468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.