Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neurodevelopmental Disorders
- Nutrition Disorder, Fetal
- Pregnancy Related
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Intervention and Control supplements will be packaged by Factors Group of Companies and labelled by contracted pharmaceutical personnel who are not involved in the trial. Study supplement bottles will be identified only by the blinded Product ID to match the randomisation schedule prepared by an independent statistician. Research Personnel will access the Randomisation Module in REDCap and women will be allocated a random, unique, re-identifiable randomisation ID. Women will be issued with supplements labelled to match their unique assigned code.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 governme...
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 ?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.
Tracking Information
- NCT #
- NCT04586348
- Collaborators
- Women's and Children's Hospital, Australia
- Flinders Medical Centre
- Mater Mothers' Hospital
- The Royal Women's Hospital
- Investigators
- Principal Investigator: Karen P Best, PhD South Australian Health and Medical Research Institute
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