drugset / Trial / NCT04586348
Prenatal Iodine Supplementation and Early Childhood Neurodevelopment
Phase 4
Unknown
794 enrolled
South Australian Health and Medical Research Institute
Flinders Medical Centre · collabMater Mothers' Hospital · collabRoyal North Shore Hospital · collabThe Royal Women's Hospital · collabWomen's and Children's Hospital, Australia · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2021-01-18
- Primary completion
- 2025-05
- Completion
- 2025-12
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Low Iodine Supplement | Unknown | 20 ug | — |
| Subject | Standard Iodine Supplement | Unknown | 200 ug | — |