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Trial registered on ANZCTR


Registration number
ACTRN12624001401549
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational study of New Zealand Pregnant WOmen inVEstigating Thyroid functioN (WOVEN).
Scientific title
Investigation of mineral intake (namely iodine, selenium, zinc, iron and sodium) with thyroid function during pregnancy in New Zealand women.
Secondary ID [1] 311756 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WOVEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid function during Pregnancy
 333260 0
Condition category
Condition code
Metabolic and Endocrine 329951 329951 0 0
Thyroid disease
Reproductive Health and Childbirth 332269 332269 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
During the study we will recruit 100 pregnant women and follow them over three time points during their pregnancy (10-15 weeks, 24-26 weeks and 34-36 weeks of pregnancy) and one further time point following the pregnancy (when infant is 6 - 8 weeks of age). Women will attend the Human Nutrition Research Unit at Massey University in Palmerston North. At each of the visit's researchers will administer 2 x questionnaires anticipated to take 20 minutes each, measure height, weight and body composition (bioelectrical impedance or BODPOD measurements) and collect samples of blood and urine. After each visit participants will be asked to complete a 3-day food diary and also to collect nail clippings which they will post back to the researchers. After birth, participants will also be asked to provide nail clippings from their infants between 6 and 8 weeks of age.

Intake (from diet and supplements) of the iodine, selenium, zinc, iron and sodium will be determined and compared to thyroid function at the three time points during pregnancy. Infant nail mineral content (selenium and zinc) will be compared to maternal intake during pregnancy.
Intervention code [1] 328240 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337754 0
To investigate thyroid function (composite of thyroid stimulating hormone (TSH), triiodothyronine (FT3), thyroxine (FT4), Anti-Thyroid Peroxidase Antibody (Anti TPO), thyroglobulin (Tg) and Tg Antibody (TgAb))
Timepoint [1] 337754 0
Once between 10 - 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks of gestation,
Primary outcome [2] 339855 0
Iodine intake
Timepoint [2] 339855 0
Once between 10-15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks of gestation
Primary outcome [3] 339856 0
Iodine status
Timepoint [3] 339856 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.
Secondary outcome [1] 433149 0
Establish creatinine in urine to correct UIC for hydration status (Primary outcome)
Timepoint [1] 433149 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.
Secondary outcome [2] 434738 0
Dietary intake
Timepoint [2] 434738 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.
Secondary outcome [3] 441656 0
Selenium status
Timepoint [3] 441656 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.
Secondary outcome [4] 441657 0
Zinc status
Timepoint [4] 441657 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.
Secondary outcome [5] 441658 0
Iron status
Timepoint [5] 441658 0
Once between 10- 15 weeks pregnancy gestation, once between 24-26 weeks pregnancy gestation and once between 34-36 weeks gestation.

Eligibility
Key inclusion criteria
Aged over 18 years old
Less than 15 weeks pregnant
Singleton pregnancy (only 1 fetus)
No history of thyroid disease.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Thyroid disfunction or disease
Under the age of 18
Non pregnant
Pregnant with more than one fetus
Over 15 weeks pregnant

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26211 0
New Zealand
State/province [1] 26211 0
Manuwatu

Funding & Sponsors
Funding source category [1] 316133 0
Government body
Name [1] 316133 0
Health Research Council of New Zealand
Country [1] 316133 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 318308 0
None
Name [1] 318308 0
Address [1] 318308 0
Country [1] 318308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314912 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314912 0
Ethics committee country [1] 314912 0
New Zealand
Date submitted for ethics approval [1] 314912 0
06/06/2024
Approval date [1] 314912 0
05/09/2024
Ethics approval number [1] 314912 0
2024 EXP 18708

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

Contacts
Principal investigator
Name 133126 0
A/Prof Louise Brough
Address 133126 0
School of Food Technology and Natural Sciences, Massey University, Palmerston North, 4442
Country 133126 0
New Zealand
Phone 133126 0
+64 6 951 6437
Fax 133126 0
Email 133126 0
L.Brough@massey.ac.nz
Contact person for public queries
Name 133127 0
Louise Brough
Address 133127 0
School of Food Technology and Natural Sciences, Massey University, Palmerston North, 4442
Country 133127 0
New Zealand
Phone 133127 0
+64 6 951 6437
Fax 133127 0
Email 133127 0
L.Brough@massey.ac.nz
Contact person for scientific queries
Name 133128 0
Louise Brough
Address 133128 0
School of Food Technology and Natural Sciences, Massey University, Palmerston North, 4442
Country 133128 0
New Zealand
Phone 133128 0
+64 6 951 6437
Fax 133128 0
Email 133128 0
L.Brough@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data
When will data be available (start and end dates)?
1/01/2027 - no end date
Available to whom?
Other researchers
Available for what types of analyses?
Meta analysis and combing data sets
How or where can data be obtained?
The data will be available via the Open Science Framework
https://osf.io


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.