A Phase 4 interventional study of Low Iodine Supplement and Standard Iodine Supplement in Pregnancy Related, Neurodevelopmental Disorders and Nutrition Disorder, Fetal, sponsored by South Australian Health and Medical Research Institute. Active, not recruiting at 1 site in Australia. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by South Australian Health and Medical Research Institute · Phase 4, Interventional, and Prevention
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.
It is known that severe iodine deficiency during pregnancy leads to profound intellectual disabilities in the child. Following results of a 2004 national survey of school-aged children showing that mild iodine deficiency had re-emerged in the south-eastern parts of Australia, the Australian government mandated the addition of iodine to salt used in bread making to increase population iodine intake. It is also recommended that all pregnant and lactating women take an additional iodine supplement containing 150 µg/d of iodine.
Since this time, further evidence has emerged from cohort studies that children born to women with high iodine intake (as well as low iodine intake) have poorer neurodevelopmental scores, suggesting that more tailored supplementation may be a better strategy. Our PoppiE trial will determine if limiting iodine supplementation in women who already consume adequate iodine from food, improves cognitive scores in early childhood.
A total of 754 pregnant women from around Australia who are ≤13 weeks of gestation will be enrolled and randomised to receive a standard prenatal vitamin and mineral supplement with a reduced amount of iodine (20 μg - intervention) or a standard prenatal vitamin and mineral supplement with 200 μg of iodine (control). The control supplement contains a level of iodine to match the amount in most commonly used vitamin and mineral supplements sold in Australia. Infant neurodevelopment at 24 months of age will be assessed using the Bayley-IV and conducted at participating centres or a location convenient to the family.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's enrollment of 794 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →South Australian Health and Medical Research Institute is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Combination Product: Low 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: Standard Iodine Supplement
Multivitamin and mineral supplement with reduced iodine
Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements
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).
Time frame: 24 months of age
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.
Time frame: 24 months of age
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.
Time frame: 24 months of age
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.
Time frame: 24 months of age
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.
Time frame: 24 months of age
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 \[280 - (estimated date of delivery - date of birth)\].
Time frame: Birth
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.
Time frame: Birth
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.
Time frame: The neonatal period including birth to 28 days of age
Thyroid stimulating hormone (TSH) level
Ascertained from Neonatal Screening Test
Time frame: Within 5 days of birth
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.
Time frame: 24 months of age
Proportion of participants with pre-eclampsia
Clinical diagnosis of pre-eclampsia as recorded in the participants handheld record.
Time frame: At any time throughout current pregnancy
Proportion of participants with induction of labour and reason for induction.
As recorded in the participants handheld record.
Time frame: Delivery
Proportion of participants with postpartum hemorrhage
Clinical diagnosis of postpartum hemorrhage as recorded in the participants handheld record.
Time frame: Within 24 hours of delivery of the infant
Proportion of participants with gestational diabetes
Clinical diagnosis of gestational diabetes as recorded in the participants handheld record.
Time frame: At any time throughout current pregnancy
Proportion of participants with induced labour
As recorded in the participants handheld record.
Time frame: Delivery
Proportion of participants with vaginal delivery
Vaginal or caesarean delivery
Time frame: Delivery
Proportion of Maternal Adverse Events per group
Side effects and tolerability of supplements will be assessed through routine data collection.
Time frame: From the date of randomization until delivery of the infant (up to 40 weeks)
Proportion of Maternal Serious Adverse Events per group
Maternal admissions to intensive care during the intervention period. Maternal death in the intervention period.
Time frame: From the date of randomization until the date of delivery (up to 40 weeks)
Proportion of Fetal/Infant Serious Adverse Events
Fetal Mortality (after randomisation and prior to birth) including; miscarriage/terminations (pregnancy loss \<20 weeks of gestation); stillbirth (intrauterine fetal death ≥20 weeks of gestation). Infant Mortality including; neonatal death (death of a live born infant in the first 28 days of life); infant death (death of an infant after the first 28 days of life). Major congenital anomalies.
Time frame: From the date of randomization until the infant is 24 months of age (up to 144 weeks)
Economic Evaluation
A within-trial cost-effectiveness analysis will be conducted comparing costs and outcomes of the trial arms. The analysis will take into account a range of cost items including cost of interventions (i.e., dietary supplements) and cost of eligibility screening. Medicare data and data held by the State departments of health will be used to estimate direct health care costs associated with the management of poor developmental health outcomes over the study period including pharmaceuticals, out of hospital services (e.g., doctor visits), and hospital services (including emergency department presentations).
Time frame: From the date of randomization until the infant is 24 months of age (up to 144 weeks)
Urinary Iodine Concentration
At baseline, median iodine concentration by state will be determined to confirm state differences in iodine status that have been previously identified and to determine balance between the two treatment groups. At 28 weeks we will examine median UIC by treatment group to assess group compliance and the success of the intervention.
Time frame: At baseline (enrolment <13 weeks of gestation) and mid-pregnancy (28 weeks of gestation)
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Following final data analysis and primary publication
Access criteria: 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.
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for May 2025, 52 months after the start.
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This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Neurodevelopmental Disorders →
South Australian Health and Medical Research Institute