SEARCHRCTobstetrics and gynecology, pediatrics

RCT·obstetrics and gynecology, pediatrics, clinical nutrition, micronutrients, endocrinology·PMC10173960

Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial

BMJ Open · 18 authors, 18 centres

AI SUMMARY

FIDELITY 100%

POPULATIONPregnant women less than 13 weeks’ gestation with an iodine intake of ≥165 µg/day from food.

INTERVENTIONLow iodine (20 µg/day) multivitamin and mineral supplement from enrolment until delivery.

COMPARISONIdentical supplement containing 200 µg/day of iodine from enrolment until delivery.

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This is a protocol for a randomised controlled trial in pregnant women with adequate dietary iodine, comparing a standard 200 µg/day iodine supplement to a low 20 µg/day supplement. The study will test if limiting iodine supplementation affects children's cognitive development at 24 months.

Full summary

898 CHARS

This paper describes the protocol for the PoppiE trial, a multicentre randomised controlled trial. It will randomise 754 pregnant women with adequate dietary iodine intake (≥165 µg/day) to receive either a standard prenatal supplement with 200 µg/day iodine or a low-iodine supplement with 20 µg/day from early pregnancy until delivery. The primary outcome is the child's cognitive development quotient at 24 months, measured by the Bayley-IV. Secondary outcomes include language, motor, and behavioural development, as well as maternal and infant clinical outcomes. The analysis plan uses linear regression to compare cognitive scores between groups. The protocol notes that this is the first trial to examine this specific question, addressing uncertainty about whether current universal iodine supplementation recommendations for pregnant women in iodine-sufficient populations might be harmful.

PICO

PPOPULATION

Pregnant women less than 13 weeks’ gestation with an iodine intake of ≥165 µg/day from food.

IINTERVENTION

Low iodine (20 µg/day) multivitamin and mineral supplement from enrolment until delivery.

OOUTCOME

Primary: Infant developmental quotient (DQ) at 24 months assessed with the Cognitive Scale of the Bayley Scales of Infant Development, fourth edition.

STUDY TYPE

RCT

SPECIALTY

obstetrics and gynecology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10173960

Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial

BMJ Open

READ THE FULL PAPER

ABSTRACT

Introduction Observational studies suggest both low and high iodine intakes in pregnancy are associated with poorer neurodevelopmental outcomes in children. This raises concern that current universal iodine supplement recommendations for pregnant women in populations considered to be iodine sufficient may negatively impact child neurodevelopment. We aim to determine the effect of reducing iodine intake from supplements for women who have adequate iodine intake from food on the cognitive development of children at 24 months of age. Methods and analysis A multicentre, randomised, controlled, clinician, researcher and participant blinded trial with two parallel groups. Using a hybrid decentralised clinical trial model, 754 women (377 per group) less than 13 weeks’ gestation with an iodine intake of ≥165 µg/day from food will be randomised to receive either a low iodine (20 µg/day) multivitamin and mineral supplement or an identical supplement containing 200) µg/day (amount commonly used in prenatal supplements in Australia), from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age assessed with the Cognitive Scale of the Bayley Scales of Infant Development, fourth edition. Secondary outcomes include infant language and motor development; behavioural and emotional development; maternal and infant clinical outcomes and health service utilisation of children. Cognitive scores will be compared between groups using linear regression, with adjustment for location of enrolment and the treatment effect described as a mean difference with 95% CI. Ethics and dissemination Ethical approval has been granted from the Women’s and Children’s Health Network Research Ethics Committee (HREC/17/WCHN/187). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals. Trial registration number NCT04586348 .

CITATION EXPORT

Karen P Best, Jacqueline F Gould, Maria Makrides et al.. Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2022-071359

AUTHORS

18 · 18 CENTRES

Karen P Best, Jacqueline F Gould, Maria Makrides, Thomas Sullivan, Jeanie Cheong, Shao J Zhou, Stefan Kane, Huda Safa, A Sparks, Lex W Doyle, A J McPhee, Tanya A C Nippita, Hossein H A Afzali, Rosalie Grivell, D Mackerras, E Knight, Simon Wood, Tim Green

1Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
2Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia
3School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia
4Newborn Services, Royal Women’s Hospital, Parkville, Victoria, Australia
5Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia
6School of Agriculture, Food & Wine, The University of Adelaide, Adelaide, South Australia, Australia
7Department of Maternal Fetal Medicine, Royal Women’s Hospital, Parkville, Victoria, Australia
8School of Medicine, University of Queensland, Brisbane, Queensland, Australia
9Department of Obstetrics and Gynaecology, Mater Mothers’ Hospital, Brisbane, Queensland, Australia
10Department of Neonatology, Royal North Shore Hospital, St Leonards, New South Wales, Australia
11Obstetrics and Gynaecology, Royal Women’s Hospital, Parkville, Victoria, Australia
12Women and Babies, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia
13Northern Clinical School, The University of Sydney, Sydney, New South Wales, Australia
14College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
15Department of Obstetrics and Gynaecology, Flinders University, Adelaide, South Australia, Australia
16Menzies School of Health Research, Casuarina, Northern Territory, Australia
17Faculty of Land and Food Systems, University of British Columbia, Victoria, British Columbia, Canada
18Faculty of Science and Engineering, Curtin University, Perth, Western Australia, Australia