Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial
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 sufficie...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e071359.full |
| _version_ | 1797829635940024320 |
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| author | Lex W Doyle Thomas Sullivan Jeanie Cheong Simon Wood Tim Green Maria Makrides Karen P Best Jacqueline F Gould A J McPhee Shao J Zhou Rosalie Grivell E Knight A Sparks Stefan Kane Huda Safa Tanya A C Nippita Hossein H A Afzali D Mackerras |
| author_facet | Lex W Doyle Thomas Sullivan Jeanie Cheong Simon Wood Tim Green Maria Makrides Karen P Best Jacqueline F Gould A J McPhee Shao J Zhou Rosalie Grivell E Knight A Sparks Stefan Kane Huda Safa Tanya A C Nippita Hossein H A Afzali D Mackerras |
| author_sort | Lex W Doyle |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T13:23:28Z |
| format | Article |
| id | doaj.art-a64a3a7c744b4c399fcb3811e4a2929c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T13:23:28Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-a64a3a7c744b4c399fcb3811e4a2929c2023-05-10T20:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2022-071359Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trialLex W Doyle0Thomas Sullivan1Jeanie Cheong2Simon Wood3Tim Green4Maria Makrides5Karen P Best6Jacqueline F Gould7A J McPhee8Shao J Zhou9Rosalie Grivell10E Knight11A Sparks12Stefan Kane13Huda Safa14Tanya A C Nippita15Hossein H A Afzali16D Mackerras173 Victorian Infant Brain Studies, Murdoch Children`s Research Institute, Melbourne, Victoria, AustraliaFaculty of Health and Medical Sciences, School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia2 Department of Obstetrics and Gynaecology, The University of Melbourne, Parkville, Victoria, AustraliaFaculty of Science and Engineering, Curtin University, Perth, West Australia, AustraliaSAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, AustraliaSAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, AustraliaWomen and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia2 School of Agriculture, Food and Wine, The University of Adelaide, Adelaide, South Australia, AustraliaDepartment of Obstetrics and Gynaecology, Flinders University, Adelaide, South Australia, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, AustraliaDepartment of Neonatology, Royal North Shore Hospital, St Leonards, New South Wales, AustraliaDepartment of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, AustraliaSchool of Medicine, University of Queensland, Brisbane, Queensland, AustraliaWomen and Babies, Kolling Institute of Medical Research, St Leonards, New South Wales, AustraliaCollege of Medicine and Public Health, Flinders University, Adelaide, South Australia, AustraliaMenzies School of Health Research, Casuarina, Northern Territory, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/13/5/e071359.full |
| spellingShingle | Lex W Doyle Thomas Sullivan Jeanie Cheong Simon Wood Tim Green Maria Makrides Karen P Best Jacqueline F Gould A J McPhee Shao J Zhou Rosalie Grivell E Knight A Sparks Stefan Kane Huda Safa Tanya A C Nippita Hossein H A Afzali D Mackerras Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial BMJ Open |
| title | Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial |
| title_full | Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial |
| title_fullStr | Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial |
| title_full_unstemmed | Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial |
| title_short | Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial – study protocol for a multicentre randomised controlled trial |
| title_sort | prenatal iodine supplementation and early childhood neurodevelopment the poppie trial study protocol for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/5/e071359.full |
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