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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04586348
Ethics application status
Date submitted
1/10/2020
Date registered
7/10/2020
Date last updated
7/10/2020

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
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

Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

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

Eligibility
Key inclusion criteria
- Pregnant women ≤13 weeks of gestation.

- Consume greater than 185 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
18 Years
Maximum age
No limit
Gender
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
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
Other
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

Ethics approval
Ethics application status

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 (>185 μg/d from food
alone) on cognitive development of children at 24 months of age.
Trial website
https://clinicaltrials.gov/show/NCT04586348
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
Karen P Best, PhD
Address 0 0
Country 0 0
Phone 0 0
+61434243404
Fax 0 0
Email 0 0
karen.best@sahmri.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04586348