Evidence map›Paper›PMID 40390018›Full record

ArticleTrials2025

Statistical analysis plan for the Prenatal Iodine Supplementation and Early Childhood Neurodevelopment (PoppiE) randomised controlled trial.

Thomas R Sullivan, Tim J Green, Jacqueline F Gould, Maria M Makrides, Karen P Best

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04586348 (Prenatal Iodine Supplementation and Early Childhood Neurodevelopment), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04586348 phase4unknown statusnot on this map

Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

TypeinterventionalSponsorSouth Australian Health and Medical Research InstituteRan2021 to 2025Enrolled794ConditionsPregnancy Related, Neurodevelopmental Disorders, Nutrition Disorder, FetalArmsLow Iodine Supplement, Standard Iodine Supplement
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Evolving Concepts in Gestational Iodine Requirements.Healthcare (Basel, Switzerland) · 2026
    Review
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Thomas R SullivanWomen and Kids Theme, South Australian Health and Medical Research Institute, Level 7, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, SA, 5006, Australia. thomas.sullivan@sahmri.com.ORCID http://orcid.org/0000-0002-6930-5406
Tim J GreenWomen and Kids Theme, South Australian Health and Medical Research Institute, Level 7, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, SA, 5006, Australia.
Jacqueline F GouldWomen and Kids Theme, South Australian Health and Medical Research Institute, Level 7, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, SA, 5006, Australia.
Maria M MakridesWomen and Kids Theme, South Australian Health and Medical Research Institute, Level 7, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, SA, 5006, Australia.
Karen P BestWomen and Kids Theme, South Australian Health and Medical Research Institute, Level 7, Women's and Children's Hospital, 72 King William Road, North Adelaide, Adelaide, SA, 5006, Australia.

Funding

Medical Research Future Fund 1199617
6 · The paper itself

Abstract

backgroundObservational evidence suggests both low and high iodine intakes in pregnancy are associated with poorer neurodevelopment in children. This raises concern that blanket recommendations for iodine supplementation in pregnancy may negatively impact child neurodevelopment in women with sufficient iodine intake from food alone.

methodsPoppiE (Prenatal Iodine Supplementation and Early Childhood Neurodevelopment) is a multi-centre, parallel, two-arm, clinician, researcher and participant blinded randomised controlled trial. Seven hundred fifty-four consenting pregnant women ≤ 13 weeks of gestation with an iodine intake of > 165 μg/day from food will be randomised to receive a multivitamin and mineral supplement containing 20 µg/day (intervention) or 200 µg/day (control) of iodine from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age as assessed with the Cognitive Scale Score of the Bayley Scales of Infant Development, 4th Edition, to be analysed using linear regression with generalised estimating equations to account for multiple births. In this article, we comprehensively detail the planned statistical analyses of the PoppiE trial, including approaches to intercurrent events, methods for handling missing data and planned sensitivity analyses.

conclusionsPoppiE is the first trial to examine the effect of prenatal iodine supplementation on early childhood development in women with sufficient iodine intake from food. At the time of writing (February 2025), recruitment into the trial is complete and data collection is due to conclude in July 2026. The statistical analysis plan was finalised before the database lock, which will ensure study conclusions are not subject to bias due to data-driven analyses.

trial registrationClinicalTrials.gov NCT04586348. Registered on October 14, 2020.

Indexed as

Child DevelopmentDietary SupplementsIodinePrenatal CareChild, PreschoolCognitionData Interpretation, StatisticalFemaleHumansInfantInfant, NewbornMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicTime FactorsIodineCognitive developmentIodinePregnancyRandomised controlled trialStatistical analysis planSupplementation

Identifiers

PMID40390018
PMCPMC12087031

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Registered trials

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