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Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

NCT04586348 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 794

Last updated 2024-04-03

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Low Iodine Supplement

Multivitamin and mineral supplement with reduced iodine

COMBINATION_PRODUCT

Standard Iodine Supplement

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

Sponsors & Collaborators

  • Women's and Children's Hospital, Australia

    collaborator OTHER_GOV

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Mater Mothers' Hospital

    collaborator OTHER

  • The Royal Women's Hospital

    collaborator UNKNOWN

  • Royal North Shore Hospital

    collaborator OTHER

  • South Australian Health and Medical Research Institute

    lead OTHER

Principal Investigators

  • Karen P Best, PhD · South Australian Health and Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586348 on ClinicalTrials.gov