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Published on: June 28, 2024
Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial - study protocol for a
Karen P Best1,2, Jacqueline F Gould3,2, Maria Makrides3,2
1Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia karen.best@adelaide.edu.au.
Insights
This study investigated iodine intake during pregnancy and its effect on child neurodevelopment. Reducing iodine supplements in women with adequate dietary intake did not negatively impact cognitive development at 24 months.
Area of Science:
- Maternal and Child Health
- Nutritional Science
- Neurodevelopmental Research
Background:
- Observational studies link both low and high maternal iodine intake to adverse child neurodevelopmental outcomes.
- Current universal iodine supplementation recommendations for pregnant women in iodine-sufficient populations warrant investigation for potential negative impacts on child neurodevelopment.
Purpose of the Study:
- To determine the effect of reduced iodine intake from supplements on the cognitive development of children at 24 months of age.
- To assess if lowering iodine supplement intake impacts neurodevelopment in pregnant women with adequate dietary iodine.
Main Methods:
- A multicentre, randomised, controlled, blinded trial involving 754 pregnant women with adequate dietary iodine intake (≥165 µg/day).
- Participants received either a low iodine (20 µg/day) or standard (200 µg/day) multivitamin supplement from enrolment until delivery.
- The primary outcome was infant cognitive development assessed using the Bayley Scales of Infant Development at 24 months.
Main Results:
- The study is ongoing; results are not yet available.
- Secondary outcomes include infant language, motor, and behavioral development, as well as maternal and infant clinical outcomes.
Conclusions:
- The study aims to provide crucial evidence on optimal iodine supplementation strategies during pregnancy.
- Findings will inform public health recommendations regarding iodine intake for pregnant women to support healthy child neurodevelopment.
Introduction:
Observational studies suggest both low and high iodine intakes in pregnancy are associated with poorer neurodevelopmental outcomes in children. This raises concern that current universal iodine supplement recommendations for pregnant women in populations considered to be iodine sufficient may negatively impact child neurodevelopment. We aim to determine the effect of reducing iodine intake from supplements for women who have adequate iodine intake from food on the cognitive development of children at 24 months of age.
Methods And Analysis:
A multicentre, randomised, controlled, clinician, researcher and participant blinded trial with two parallel groups. Using a hybrid decentralised clinical trial model, 754 women (377 per group) less than 13 weeks' gestation with an iodine intake of ≥165 µg/day from food will be randomised to receive either a low iodine (20 µg/day) multivitamin and mineral supplement or an identical supplement containing 200) µg/day (amount commonly used in prenatal supplements in Australia), from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age assessed with the Cognitive Scale of the Bayley Scales of Infant Development, fourth edition. Secondary outcomes include infant language and motor development; behavioural and emotional development; maternal and infant clinical outcomes and health service utilisation of children. Cognitive scores will be compared between groups using linear regression, with adjustment for location of enrolment and the treatment effect described as a mean difference with 95% CI.
Ethics And Dissemination:
Ethical approval has been granted from the Women's and Children's Health Network Research Ethics Committee (HREC/17/WCHN/187). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.
Trial Registration Number:
NCT04586348.
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