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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04586348


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04586348
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020

Titles & IDs
Public title
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Scientific title
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Secondary ID [1] 0 0
PoppiE
Universal Trial Number (UTN)
Trial acronym
PoppiE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related 0 0
Neurodevelopmental Disorders 0 0
Nutrition Disorder, Fetal 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Low Iodine Supplement
Other interventions - Standard Iodine Supplement

Experimental: Low Iodine Supplement - Iodine (potassium iodide) 20 µg Beta carotene (All trans-beta- carotene) 1500 µg; Vitamin E (dl-alphatocopheryl acetate) 13.5 mg AT; Vitamin D3 (cholecalciferol) 10 µg; Vitamin C (ascorbic acid granular) 60 mg; Niacinamide 18 mg; Pantothenic acid (calcium d- pantothenate) 6 mg; Vitamin B6 (DC pyridoxine hydrochloride) 1.9 mg; Vitamin B1 (thiamine mononitrate) 1.4 mg; Vitamin B2 (riboflavin) 1.4 mg; Biotin 30 µg; Vitamin B12 (methyl-cobalamin) 2.6 µg; Folic Acid 0.4 mg; Levomefolic acid 0.1 mg; Calcium (carbonate DC) 250 mg; Magnesium (oxide granular) 50 mg; Iron (ferrous fumarate) 20 mg; Zinc (oxide) 10 mg; Manganese (sulphate) 2 mg; Copper (sulphate) 1 mg; Selenium (rice chelate) 30 µg

Active comparator: Standard Iodine Supplement - Iodine (potassium iodide) 200 µg Beta carotene (All trans-beta- carotene) 1500 µg; Vitamin E (dl-alphatocopheryl acetate) 13.5 mg AT; Vitamin D3 (cholecalciferol) 10 µg; Vitamin C (ascorbic acid granular) 60 mg; Niacinamide 18 mg; Pantothenic acid (calcium d- pantothenate) 6 mg; Vitamin B6 (DC pyridoxine hydrochloride) 1.9 mg; Vitamin B1 (thiamine mononitrate) 1.4 mg; Vitamin B2 (riboflavin) 1.4 mg; Biotin 30 µg; Vitamin B12 (methyl-cobalamin) 2.6 µg; Folic Acid 0.4 mg; Levomefolic acid 0.1 mg; Calcium (carbonate DC) 250 mg; Magnesium (oxide granular) 50 mg; Iron (ferrous fumarate) 20 mg; Zinc (oxide) 10 mg; Manganese (sulphate) 2 mg; Copper (sulphate) 1 mg; Selenium (rice chelate) 30 µg


Other interventions: Low Iodine Supplement
Multivitamin and mineral supplement with reduced iodine

Other interventions: Standard Iodine Supplement
Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Infant Developmental quotient (DQ)
Timepoint [1] 0 0
24 months of age
Secondary outcome [1] 0 0
Language development of infants using Bayley-IV
Timepoint [1] 0 0
24 months of age
Secondary outcome [2] 0 0
Motor development of infants
Timepoint [2] 0 0
24 months of age
Secondary outcome [3] 0 0
Behavioral and emotional development
Timepoint [3] 0 0
24 months of age
Secondary outcome [4] 0 0
Health service utilization
Timepoint [4] 0 0
24 months of age
Secondary outcome [5] 0 0
Length of gestation
Timepoint [5] 0 0
Birth
Secondary outcome [6] 0 0
Infant Birth Anthropometrics
Timepoint [6] 0 0
Birth
Secondary outcome [7] 0 0
Admission to special care baby unit (level 2 nursery).
Timepoint [7] 0 0
The neonatal period including birth to 28 days of age
Secondary outcome [8] 0 0
Thyroid stimulating hormone (TSH) level
Timepoint [8] 0 0
Within 5 days of birth
Secondary outcome [9] 0 0
Infant Anthropometrics
Timepoint [9] 0 0
24 months of age

Eligibility
Key inclusion criteria
* Pregnant women =13 weeks of gestation.
* Consume greater than 165 µg/d of iodine from food alone based on our validated Iodine Specific Food Frequency Questionnaire (I-FFQ).
* English is main language spoken at home as child will need to understand and take instruction in English to participate in the neurodevelopmental assessment.
* Able to give informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Known history of thyroid disease.
* Previous child diagnosed with thyroid dysfunction.
* Carrying a fetus with a known or suspected congenital abnormality.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
794
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
South Australian Health and Medical Research Institute - North Adelaide
Recruitment postcode(s) [1] 0 0
5081 - North Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Women's and Children's Hospital, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Flinders Medical Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Mater Mothers' Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Royal Women's Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Royal North Shore Hospital
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Karen P Best, PhD
Address 0 0
South Australian Health and Medical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to study data may be granted, upon review and approval of the HREC, trial steering committee and in accordance with SAHMRI W\&K 'Guidelines and Agreement for the use of materials in an ancillary study associated with original clinical trials or cohort studies.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Following final data analysis and primary publication
Available to whom?
Access to study data may be granted, upon review and approval of the HREC, trial steering committee and in accordance with SAHMRI W\&K 'Guidelines and Agreement for the use of materials in an ancillary study associated with original clinical trials or cohort studies.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04586348

Additional trial details provided through ANZCTR
Accrual to date
640
Recruiting in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Funding & Sponsors
Funding source category [1] 43
Government body
Name [1] 43
Medical Research Futures Fund
Address [1] 43
Canberra
Country [1] 43
Australia
Primary sponsor
Government body
Primary sponsor name
South Australian Health and Medical Research Institute (SAHMRI)
Primary sponsor address
North Terrace, Adelaide, South Australia
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 20
Women's and Children's Health Network
Address [1] 20
72 King William Road
Country [1] 20
Australia
Date submitted for ethics approval [1] 20
23/09/2020
Approval date [1] 20
Ethics approval number [1] 20
 
Public notes

Contacts
Principal investigator
Title 193 0
Dr
Name 193 0
Karen Best
Address 193 0
72 King William Road
Country 193 0
Australia
Phone 193 0
+61 08 8128 4404
Fax 193 0
Email 193 0
[email protected]
Contact person for public queries
Title 194 0
Dr
Name 194 0
Karen Best
Address 194 0
72 King William Road
Country 194 0
Australia
Phone 194 0
+61 08 8128 4404
Fax 194 0
Email 194 0
[email protected]
Contact person for scientific queries
Title 195 0
Dr
Name 195 0
Karen Best
Address 195 0
72 King William Road
Country 195 0
Australia
Phone 195 0
+61 08 8128 4404
Fax 195 0
Email 195 0
[email protected]