Clinical trial NCT04586348: Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Official title: Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Pregnancy Related
Neurodevelopmental Disorders
Nutrition Disorder, Fetal
Keywords: Iodine
Supplementation
Lead sponsor: South Australian Health and Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Women's and Children's Hospital, Australia
name: Flinders Medical Centre
name: Mater Mothers' Hospital
name: The Royal Women's Hospital
name: Royal North Shore Hospital
First posted: 2020-10-14
Enrollment: 794
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, randomised, controlled, clinician, researcher and participant blinded trial with two parallel groups. An independent statistician not otherwise involved in the study or data analysis will generate and keep the randomisation schedule. The computer-generated schedule will allocate women to intervention or control groups in the ratio of 1:1 using randomly permuted blocks of size 6 and 8, with stratification for state of enrolment.

Randomisations will be performed by approved study staff via a secure web-based randomisation service.
Primary purpose: PREVENTION

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.

Detailed 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 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Known history of thyroid disease.
* Previous child diagnosed with thyroid dysfunction.
* Carrying a fetus with a known or suspected congenital abnormality.

Primary outcomes:
measure: Infant Developmental quotient (DQ)
timeFrame: 24 months of age
Secondary outcomes:
measure: Language development of infants using Bayley-IV
timeFrame: 24 months of age
measure: Motor development of infants
timeFrame: 24 months of age
measure: Behavioral and emotional development
timeFrame: 24 months of age
measure: Health service utilization
timeFrame: 24 months of age
measure: Length of gestation
timeFrame: Birth
measure: Infant Birth Anthropometrics
timeFrame: Birth
measure: Admission to special care baby unit (level 2 nursery).
timeFrame: The neonatal period including birth to 28 days of age
measure: Thyroid stimulating hormone (TSH) level
timeFrame: Within 5 days of birth
measure: Infant Anthropometrics
timeFrame: 24 months of age
Other outcomes:
measure: Proportion of participants with pre-eclampsia
timeFrame: At any time throughout current pregnancy
measure: Proportion of participants with induction of labour and reason for induction.
timeFrame: Delivery
measure: Proportion of participants with postpartum hemorrhage
timeFrame: Within 24 hours of delivery of the infant
measure: Proportion of participants with gestational diabetes
timeFrame: At any time throughout current pregnancy
measure: Proportion of participants with induced labour
timeFrame: Delivery
measure: Proportion of participants with vaginal delivery
timeFrame: Delivery
measure: Proportion of Maternal Adverse Events per group
timeFrame: From the date of randomization until delivery of the infant (up to 40 weeks)
measure: Proportion of Maternal Serious Adverse Events per group
timeFrame: From the date of randomization until the date of delivery (up to 40 weeks)
measure: Proportion of Fetal/Infant Serious Adverse Events
timeFrame: From the date of randomization until the infant is 24 months of age (up to 144 weeks)
measure: Economic Evaluation
timeFrame: From the date of randomization until the infant is 24 months of age (up to 144 weeks)
measure: Urinary Iodine Concentration
timeFrame: At baseline (enrolment <13 weeks of gestation) and mid-pregnancy (28 weeks of gestation)
Locations:
city: North Adelaide
country: Australia
facility: South Australian Health and Medical Research Institute
state: South Australia
Study officials:
affiliation: South Australian Health and Medical Research Institute
name: Karen P Best, PhD
role: PRINCIPAL_INVESTIGATOR
References: