Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

  • STATUS
    Recruiting
  • End date
    Dec 7, 2025
  • participants needed
    754
  • sponsor
    South Australian Health and Medical Research Institute
Updated on 7 August 2021

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 g/d from food alone) on cognitive development of children at 24 months of age.

Description

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 g/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 g - intervention) or a standard prenatal vitamin and mineral supplement with 200 g 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.

Details
Condition Fetal Malnutrition, Neurodevelopmental Disorder, Pregnancy Related, Neurodevelopmental Disorders
Treatment Low Iodine Supplement, Standard Iodine Supplement
Clinical Study IdentifierNCT04586348
SponsorSouth Australian Health and Medical Research Institute
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant women 13 weeks of gestation
Consume greater than 165 g/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

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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