Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Related Neurodevelopmental Disorders Nutrition Disorder, Fetal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Low Iodine Supplement

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

Group Type EXPERIMENTAL

Low Iodine Supplement

Intervention Type COMBINATION_PRODUCT

Multivitamin and mineral supplement with reduced iodine

Standard 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

Group Type ACTIVE_COMPARATOR

Standard Iodine Supplement

Intervention Type COMBINATION_PRODUCT

Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements

Interventions

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Low Iodine Supplement

Multivitamin and mineral supplement with reduced iodine

Intervention Type COMBINATION_PRODUCT

Standard Iodine Supplement

Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes