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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Date last updated
3/04/2024
Titles & IDs
Public title
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
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Scientific title
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
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Secondary ID [1]
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PoppiE
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Universal Trial Number (UTN)
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Trial acronym
PoppiE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy Related
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Neurodevelopmental Disorders
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Nutrition Disorder, Fetal
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Condition category
Condition code
Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Diet and Nutrition
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Other diet and nutrition disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Combination Product - Low Iodine Supplement
Combination Product - 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
Combination Product: Low Iodine Supplement
Multivitamin and mineral supplement with reduced iodine
Combination Product: Standard Iodine Supplement
Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements
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Intervention code [1]
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Combination Product
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Infant Developmental quotient (DQ)
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Assessment method [1]
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The Bayley Scales of Infant and Toddler Development, 4th Edition Cognitive Scale score has a mean of 100 and standard deviation of 15, where higher scores indicate a better outcome. As the Bayley scales are age-standardized scales the exact minimum and maximum score depends on the exact age of the child at the time of the assessment, hence we have instead provided the mean and standard deviation (as is the norm when reporting standardized psychometric assessments).
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Timepoint [1]
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24 months of age
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Secondary outcome [1]
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Language development of infants using Bayley-IV
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Assessment method [1]
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The Bayley Scales of Infant and Toddler Development, 4th Edition Language Scale score has a mean of 100 and standard deviation of 15, where higher scores indicate a better outcome.
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Timepoint [1]
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24 months of age
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Secondary outcome [2]
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Motor development of infants
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Assessment method [2]
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The Bayley Scales of Infant and Toddler Development, 4th Edition Motor Scale score has a mean of 100 and standard deviation of 15, where higher scores indicate a better outcome.
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Timepoint [2]
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24 months of age
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Secondary outcome [3]
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Behavioral and emotional development
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Assessment method [3]
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Behavioral and emotional development of infants using the Infant Toddler Social Emotional Assessment (ITSEA). The Infant-Toddler Social & Emotional Assessment scale has range of 0-100 where higher T scores indicate a worse outcome.
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Timepoint [3]
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24 months of age
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Secondary outcome [4]
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Health service utilization
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Assessment method [4]
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Health service utilisation of children assessed through data linkage of the Medicare Benefits Schedule, Pharmaceutical Benefits Scheme to evaluate the cost effectiveness of the intervention.
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Timepoint [4]
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24 months of age
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Secondary outcome [5]
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Length of gestation
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Assessment method [5]
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The gestational age in days at birth (or other event of interest) will be determined from the estimated date of delivery using the equation [280 - (estimated date of delivery - date of birth)].
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Timepoint [5]
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Birth
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Secondary outcome [6]
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Infant Birth Anthropometrics
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Assessment method [6]
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Infant weight, length and head circumference will be analysed, using both the raw measurements and Z-scores for corresponding gestational age and sex, using means and standard deviations.
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Timepoint [6]
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Birth
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Secondary outcome [7]
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Admission to special care baby unit (level 2 nursery).
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Assessment method [7]
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Any admission to a special care baby unit or level 2 nursery up to 28 days post birth.
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Timepoint [7]
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The neonatal period including birth to 28 days of age
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Secondary outcome [8]
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Thyroid stimulating hormone (TSH) level
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Assessment method [8]
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Ascertained from Neonatal Screening Test
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Timepoint [8]
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Within 5 days of birth
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Secondary outcome [9]
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Infant Anthropometrics
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Assessment method [9]
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Average weight, height and head circumference measurements at 24 months of age will be converted to z-scores using WHO growth standards. For preterm infants, corrected age at the time of the measurement rather than chronological age will be used in deriving the z-scores.
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Timepoint [9]
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24 months of age
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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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Known history of thyroid disease.
- Previous child diagnosed with thyroid dysfunction.
- Carrying a fetus with a known or suspected congenital abnormality.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
794
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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South Australian Health and Medical Research Institute - North Adelaide
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Recruitment postcode(s) [1]
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5081 - North Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
South Australian Health and Medical Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Women's and Children's Hospital, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Flinders Medical Centre
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Mater Mothers' Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The Royal Women's Hospital
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Royal North Shore Hospital
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
A randomized controlled trial to determine the effect of reducing iodine from vitamin and
mineral supplements for pregnant women who have adequate iodine intakes (>165 µg/d from food
alone) on cognitive development of children at 24 months of age.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04586348
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Karen P Best, PhD
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Address
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South Australian Health and Medical Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/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]
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Medical Research Futures Fund
Address [1]
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Canberra
Country [1]
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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]
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Women's and Children's Health Network
Address [1]
20
72 King William Road
Country [1]
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Australia
Date submitted for ethics approval [1]
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23/09/2020
Approval date [1]
20
Ethics approval number [1]
20
Public notes
Contacts
Principal investigator
Title
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Dr
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Name
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Karen Best
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Address
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72 King William Road
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Country
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Australia
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Phone
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+61 08 8128 4404
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Dr
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Name
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Karen Best
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Address
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72 King William Road
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Country
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Australia
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Phone
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+61 08 8128 4404
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Karen Best
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Address
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72 King William Road
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Country
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Australia
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Phone
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+61 08 8128 4404
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Fax
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Email
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[email protected]
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