Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

NCT04586348 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: PoppiE
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Neurodevelopmental Disorders; Nutrition Disorder, Fetal

Keywords

Iodine; Supplementation

Outcome Measures

Primary Outcomes (1)

• Infant Developmental quotient (DQ)

  The Bayley Scales of Infant and Toddler Development, 4th Edition Cognitive Scale score has a mean of 100 and standard deviation of 15, where higher scores indicate a better outcome. As the Bayley scales are age-standardized scales the exact minimum and maximum score depends on the exact age of the child at the time of the assessment, hence we have instead provided the mean and standard deviation (as is the norm when reporting standardized psychometric assessments).

  24 months of age

Secondary Outcomes (9)

• Language development of infants using Bayley-IV

  24 months of age

• Motor development of infants

  24 months of age

• Behavioral and emotional development

  24 months of age

• Health service utilization

  24 months of age

• Length of gestation

  Birth

Other Outcomes (11)

• Proportion of participants with pre-eclampsia

  At any time throughout current pregnancy

• Proportion of participants with induction of labour and reason for induction.

  Delivery

• Proportion of participants with postpartum hemorrhage

  Within 24 hours of delivery of the infant

Study Arms (2)

Low Iodine Supplement

EXPERIMENTAL

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

Combination Product: Low Iodine Supplement

Standard Iodine Supplement

ACTIVE COMPARATOR

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

Combination Product: Standard Iodine Supplement

Interventions

Low Iodine Supplement COMBINATION_PRODUCT

Multivitamin and mineral supplement with reduced iodine

Low Iodine Supplement

Standard Iodine Supplement COMBINATION_PRODUCT

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

Standard Iodine Supplement

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• South Australian Health and Medical Research Institute: lead
• Women's and Children's Hospital, Australia: collaborator
• Flinders Medical Centre: collaborator
• Mater Mothers' Hospital: collaborator
• The Royal Women's Hospital: collaborator
• Royal North Shore Hospital: collaborator

Study Sites (1)

South Australian Health and Medical Research Institute

North Adelaide, South Australia, 5081, Australia

Location

Related Publications (2)

• Sullivan TR, Green TJ, Gould JF, Makrides MM, Best KP. Statistical analysis plan for the Prenatal Iodine Supplementation and Early Childhood Neurodevelopment (PoppiE) randomised controlled trial. Trials. 2025 May 19;26(1):162. doi: 10.1186/s13063-025-08863-1.

  PMID: 40390018 DERIVED

• Best KP, Gould JF, Makrides M, Sullivan T, Cheong J, Zhou SJ, Kane S, Safa H, Sparks A, Doyle LW, McPhee AJ, Nippita TAC, Afzali HHA, Grivell R, Mackerras D, Knight E, Wood S, Green T. Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial - study protocol for a multicentre randomised controlled trial. BMJ Open. 2023 May 10;13(5):e071359. doi: 10.1136/bmjopen-2022-071359.

  PMID: 37164467 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Fetal Nutrition Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Karen P Best, PhD

  South Australian Health and Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: January 18, 2021
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Following final data analysis and primary publication
• Access Criteria: Access to study data may be granted, upon review and approval of the HREC, trial steering committee and in accordance with SAHMRI W\&K 'Guidelines and Agreement for the use of materials in an ancillary study associated with original clinical trials or cohort studies.

Locations

AU (1)