Cognitive Developmental DelayHibaNCT03552341
Iodine Status in Pregnancy and Associated Health Outcomes
An observational study of Cognitive Developmental Delay and Birth Weight, run by University of Leeds.
Trial summary
Iodine is a key micronutrient in the diet, essential for healthy growth, and is particularly important during pregnancy and breastfeeding when demands are increased to support the developing baby. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cognitive Developmental Delay, Birth Weight
- What is being tested?
- Maternal iodine status
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The Born in Bradford cohort profile is published here: [doi:10.1093/ije/dys112] All women booked for delivery at the Bradford Royal Infirmary at 26-28 weeks gestation. All of the recruited women who provided urine samples are included in our Born in Bradford analysis. The Hiba longitudinal study replicates this process, but at the 12 week dating scan.
Who may be able to join
- Female (Both Born in Bradford and Hiba longitudinal cohorts)
- Able to provide informed consent (Both Born in Bradford and Hiba longitudinal cohorts)
- Confirmed pregnant at 26-28 week Oral Glucose Tolerance Test (OGTT) (Born in Bradford cohort)
- Confirmed 9-15 weeks pregnant at 12 week dating scan (Hiba longitudinal cohort)
- Aged 18-40 years (Hiba longitudinal cohort)
- No medical or known first degree family history of a thyroid condition (Hiba longitudinal cohort).
Who cannot join
- Inability to provide informed consent (Both Born in Bradford and Hiba longitudinal cohorts)
- Current or former medical history of thyroid disease (Hiba longitudinal cohort)
- Use of thyroid related medications (Hiba longitudinal cohort)
About this study
Official title: Assessing Iodine Status and Associated Health Outcomes in British Women During Pregnancy
Iodine is a key micronutrient in the diet, essential for healthy growth, and is particularly important during pregnancy and breastfeeding when demands are increased to support the developing baby. Many people are thought to lack all the iodine they need, and this is a greater issue during and shortly after pregnancy when the body's iodine requirements are greatest. Iodine deficiency complications are potentially serious for both mother and child. Iodine deficiency can lead to thyroid enlargement, lower production of important hormones produced by the thyroid, pregnancy complications in the mother, and impaired growth and developmental problems in babies and children. This research will focus on providing an up-to-date estimate of how many pregnant women do not have enough iodine, and what different levels of iodine might mean in terms of health risks during pregnancy and for childhood development. The investigators will investigate how iodine levels vary over the course of pregnancy and lactation, how this is affected by diet, associated changes in thyroid size and function, and what levels of iodine are linked with greater risk of subsequent health problems. The research will take advantage of existing urine samples collected from mothers during pregnancy in the Born in Bradford birth cohort study, where the investigators also know of any adverse pregnancy outcomes, as well as any developmental problems for the baby and in early childhood.
Read the detailed description
Background: Pregnant women may be particularly vulnerable to iodine deficiency as requirements increase to support fetal development. There is limited information concerning how maternal iodine status changes during pregnancy. Severe iodine deficiency is associated with deleterious health outcomes during pregnancy including gestational diabetes, preeclampsia, stillbirth, and increased mortality. For the fetus, severe iodine deficiency results in reduced birthweight, increased mortality and neurodevelopmental issues. Several studies suggest 40% of pregnant mothers in the United Kingdom (UK) may not meet the World Health Organization (WHO) definition of iodine sufficiency. Although the effects of severe iodine deficiency are known, the impact of mild-to-moderate deficiencies on maternal health and associated fetal and childhood development are not well understood.
Aims:
- To provide up-to-date information on iodine status in pregnant women in the UK, including changes during pregnancy and lactation, and the role of diet.
- To quantify any associations between iodine status during pregnancy, pregnancy outcomes, and cognitive and motor development of the child.
- To compare the iodine status of mothers in the Born in Bradford cohort to a more nationally representative sample.
Research plan and methods: The investigators will utilize the Born in Bradford (BiB) birth cohort which recruited over 12000 pregnant women between 2007- 2009, and has deposited in a biobank 6971 spot urine samples collected at 26-28 weeks gestation.
Data are available on health outcomes during pregnancy including gestational diabetes, preeclampsia, blood pressure, length of gestation, mortality, mental health. Child outcome measures at birth include weight, length, head circumference, small-for-gestational-age. Childhood developmental measures include height, weight, growth trajectories, motor skills, literacy, numeracy and mental health (Strengths and Difficulties Questionnaire, SDQ). Linkage with educational outcomes has been achieved, including Early Years Foundation Stage (EYFS) outcomes and Standard Assessment Tests (SATS) at both Key Stage 1 (KS1) and Key Stage 2 (KS2).
The investigators will measure all maternal urine samples in BiB to allow sufficient power to detect potential modest-sized associations. This will be conducted using Inductively Coupled Plasma Mass Spectrometry (ICPMS). All maternal baseline characteristics and associated outcome data are available for extraction from the primary BiB database.
The investigators will apply multiple logistic regression and multiple linear regression to ascertain potential associations between maternal iodine status and health and developmental outcomes. Cubic splines will be used to model any nonlinear dose-response associations, making no assumptions regarding any predefined thresholds.
The investigators will also conduct a longitudinal substudy to ascertain how iodine status varies between trimesters (The Hiba study). 200 pregnant women will be recruited at 12 week dating scans and the following collected: baseline characteristics, urine samples for iodide analysis, blood for thyroid stimulating hormone (TSH), free thyroxine (fT4) and triiodothyronine (fT3), thyroglobulin, Glomerular Filtration Rate (GFR) based on serum creatinine, visual inspection of the thyroid using standard methods, dietary intake using a validated online 24h recall tool (myfood24). Data collection will be repeated at 26 and 36 weeks' gestation, and 6, 18 and 30 weeks postpartum. The proposed substudy will clarify how iodine status alters in pregnancy and lactation, and any associated thyroid hormone changes. The investigators will identify key sources of iodine in the diet and ascertain dietary patterns associated with different iodine status. To compare results to a more nationally representative sample, spot urines will be analysed from approximately 650 women in the SCOPE birth-cohort (London, Leeds and Manchester).
- Conditions
- Cognitive Developmental Delay, Birth Weight
- Being tested
- Maternal iodine status
- Keywords
- Iodine, Cognitive function, Birth outcomes, Pregnancy
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal iodine statusOther
Urinary iodine concentration during pregnancy at 26 weeks' gestation (Bord in Bradford study) and at 12, 26 and 36 weeks' gestation, 6, 18 and 30 weeks postpartum (Hiba longitudinal study). This is primarily in the form of Iodine to Creatinine ratio, to take spot urine volume into account. There is no intervention in this observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Born in Bradford: Early Years Foundation Stage (EYFS) profiles
The EYFS average points total over 17 domains (score range 17 to 41) and summarised using achievement of Good Level of Development (GLD) (binary).
Measured: Ages 3 to 5
Secondary outcomes (16)
Born in Bradford: Key Stage 1 (KS1) educational outcomes
Year 1 phonics screening test (score range 0 to 40) and KS1 SATS scores in Reading, Writing, Mathematics and Science (working securely at level 2b or beyond pre-2016 or working at the expected standard or beyond for 2016 onwards, binary) will be presented.
Measured: Ages 5 to 8
Born in Bradford: Letter identification
Letter identification (standardised)
Measured: Ages 3 to 5
Born in Bradford: Receptive vocabulary
Receptive vocabulary using the British Picture Vocabulary Scale (BPVS)(standardised)
Measured: Ages 3 to 5
Born in Bradford: Social functioning
Social functioning using the Strengths and Difficulties Questionnaire (SDQ) total difficulty score and split by domains (e.g. internalising and externalising)
Measured: Ages 3 to 5
Born in Bradford: Fine motor skills
Fine motor skills using the Clinical Kinematic Assessment Tool (CKAT) overall battery score, along with Tracking, Aiming and Tracing CKAT sub-scores.
Measured: Ages 3 to 5
Born in Bradford: Birth weight centile
The main birth outcome of interest is birth weight centile, calculated using the version 8.0.1 of the Bulk centile calculator provided by the Gestation Network based at the Perinatal Institute for Maternal and Child Health
Measured: At birth
Born in Bradford: Apgar score
Apgar score (ordinal).
Measured: At 1 minute and 5 minutes after birth.
Born in Bradford: Diagnosis of autism
Confirmed diagnosis of autism based on Read codes in linked General Practitioner records.
Measured: Up to age 11.
Born in Bradford: Diagnosis of attention deficit hyperactivity disorder (ADHD)
Confirmed diagnosis of attention deficit hyperactivity disorder (ADHD) based on Read codes in linked General Practitioner records.
Measured: Up to age 11.
Hiba longitudinal study: Urinary iodine status
The main outcome of interest is urinary iodine status (primarily in the form of iodine to creatinine ratio to take account of spot urine volumes) changes during pregnancy and lactation (continuous)
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroid stimulating hormone (TSH)
Changes in thyroid stimulating hormone (TSH) during gestation and lactation.
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: triiodothyronine (fT3)
Changes in triiodothyronine (fT3) during gestation and lactation.
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: free thyroxine (fT4)
Changes in free thyroxine (fT4) during gestation and lactation.
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroglobulin
Changes in thyroglobulin during gestation and lactation.
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroid size
Changes in thyroid size, measured by palpation, using a standard protocol, during gestation and lactation.
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: maternal dietary iodine intake (micrograms)
Identification of highest ranking food items in terms of contribution to iodine in the maternal diet as measured using the myfood24 tool
Measured: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Feb 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Darren Greenwood, University of Leeds
- Investigators
- Darren C Greenwood, PhD, Principal investigator, University of LeedsLaura J Hardie, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552341
- Sponsor's protocol ID
- PR-R10-0514-11004
- Acronym
- Hiba
- Status last verified
- Oct 2021
- First submitted
- 11 May 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Born in Bradford welcomes collaboration with other researchers. The BiB website has details of how to submit expressions of interest and has short proformas for these. All suggestions will be reviewed by the BiB Executive Group on a monthly basis, and we aim to get back to potential collaborators within 8 weeks.
Publications
Snart CJP, Keeble C, Taylor E, Cade JE, Stewart PM, Zimmermann M, Reid S, Threapleton DE, Poston L, Myers JE, Simpson NAB, Greenwood DC, Hardie LJ. Maternal Iodine Status and Associations with Birth Outcomes in Three Major Cities in the United Kingdom. Nutrients. 2019 Feb 20;11(2):441. doi: 10.3390/nu11020441.
PubMed 30791590Snart CJP, Threapleton DE, Keeble C, Taylor E, Waiblinger D, Reid S, Alwan NA, Mason D, Azad R, Cade JE, Simpson NAB, Meadows S, McKillion A, Santorelli G, Waterman AH, Zimmermann M, Stewart PM, Wright J, Mon-Williams M, Greenwood DC, Hardie LJ. Maternal iodine status, intrauterine growth, birth outcomes and congenital anomalies in a UK birth cohort. BMC Med. 2020 Jun 11;18(1):132. doi: 10.1186/s12916-020-01602-0.
PubMed 32522280Threapleton DE, Snart CJP, Keeble C, Waterman AH, Taylor E, Mason D, Reid S, Azad R, Hill LJB, Meadows S, McKillion A, Alwan NA, Cade JE, Simpson NAB, Stewart PM, Zimmermann M, Wright J, Waiblinger D, Mon-Williams M, Hardie LJ, Greenwood DC. Maternal iodine status in a multi-ethnic UK birth cohort: Associations with child cognitive and educational development. Paediatr Perinat Epidemiol. 2021 Mar;35(2):236-246. doi: 10.1111/ppe.12719. Epub 2020 Sep 1.
PubMed 32870514Threapleton DE, Waiblinger D, Snart CJP, Taylor E, Keeble C, Ashraf S, Bi S, Ajjan R, Azad R, Hancock N, Mason D, Reid S, Cromie KJ, Alwan NA, Zimmermann M, Stewart PM, Simpson NAB, Wright J, Cade JE, Hardie LJ, Greenwood DC. Prenatal and Postpartum Maternal Iodide Intake from Diet and Supplements, Urinary Iodine and Thyroid Hormone Concentrations in a Region of the United Kingdom with Mild-to-Moderate Iodine Deficiency. Nutrients. 2021 Jan 14;13(1):230. doi: 10.3390/nu13010230.
PubMed 33466826Cromie KJ, Threapleton DE, Snart CJP, Taylor E, Mason D, Wright B, Kelly B, Reid S, Azad R, Keeble C, Waterman AH, Meadows S, McKillion A, Alwan NA, Cade JE, Simpson NAB, Stewart PM, Zimmermann M, Wright J, Waiblinger D, Mon-Williams M, Hardie LJ, Greenwood DC. Maternal iodine status in a multi-ethnic UK birth cohort: associations with autism spectrum disorder. BMC Pediatr. 2020 Dec 5;20(1):544. doi: 10.1186/s12887-020-02440-y.
PubMed 33276760
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Iodine Status and Associated Health Outcomes in British Women During Pregnancy
- ClinicalTrials.gov ID
- NCT03552341
- Acronym / sponsor ID
- Hiba / PR-R10-0514-11004
- Conditions
- Cognitive Developmental Delay, Birth Weight
- Keywords
- Iodine, Cognitive function, Birth outcomes, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iodine is a key micronutrient in the diet, essential for healthy growth, and is particularly important during pregnancy and breastfeeding when demands are increased to support the developing baby. Many people are thought to lack all the iodine they need, and this is a greater issue during and shortly after pregnancy when the body's iodine requirements are greatest. Iodine deficiency complications are potentially serious for both mother and child. Iodine deficiency can lead to thyroid enlargement, lower production of important hormones produced by the thyroid, pregnancy complications in the mother, and impaired growth and developmental problems in babies and children. This research will focus on providing an up-to-date estimate of how many pregnant women do not have enough iodine, and what different levels of iodine might mean in terms of health risks during pregnancy and for childhood development. The investigators will investigate how iodine levels vary over the course of pregnancy and lactation, how this is affected by diet, associated changes in thyroid size and function, and what levels of iodine are linked with greater risk of subsequent health problems. The research will take advantage of existing urine samples collected from mothers during pregnancy in the Born in Bradford birth cohort study, where the investigators also know of any adverse pregnancy outcomes, as well as any developmental problems for the baby and in early childhood.
Detailed description
Background: Pregnant women may be particularly vulnerable to iodine deficiency as requirements increase to support fetal development. There is limited information concerning how maternal iodine status changes during pregnancy. Severe iodine deficiency is associated with deleterious health outcomes during pregnancy including gestational diabetes, preeclampsia, stillbirth, and increased mortality. For the fetus, severe iodine deficiency results in reduced birthweight, increased mortality and neurodevelopmental issues. Several studies suggest 40% of pregnant mothers in the United Kingdom (UK) may not meet the World Health Organization (WHO) definition of iodine sufficiency. Although the effects of severe iodine deficiency are known, the impact of mild-to-moderate deficiencies on maternal health and associated fetal and childhood development are not well understood.
Aims:
- To provide up-to-date information on iodine status in pregnant women in the UK, including changes during pregnancy and lactation, and the role of diet.
- To quantify any associations between iodine status during pregnancy, pregnancy outcomes, and cognitive and motor development of the child.
- To compare the iodine status of mothers in the Born in Bradford cohort to a more nationally representative sample.
Research plan and methods: The investigators will utilize the Born in Bradford (BiB) birth cohort which recruited over 12000 pregnant women between 2007- 2009, and has deposited in a biobank 6971 spot urine samples collected at 26-28 weeks gestation.
Data are available on health outcomes during pregnancy including gestational diabetes, preeclampsia, blood pressure, length of gestation, mortality, mental health. Child outcome measures at birth include weight, length, head circumference, small-for-gestational-age. Childhood developmental measures include height, weight, growth trajectories, motor skills, literacy, numeracy and mental health (Strengths and Difficulties Questionnaire, SDQ). Linkage with educational outcomes has been achieved, including Early Years Foundation Stage (EYFS) outcomes and Standard Assessment Tests (SATS) at both Key Stage 1 (KS1) and Key Stage 2 (KS2).
The investigators will measure all maternal urine samples in BiB to allow sufficient power to detect potential modest-sized associations. This will be conducted using Inductively Coupled Plasma Mass Spectrometry (ICPMS). All maternal baseline characteristics and associated outcome data are available for extraction from the primary BiB database.
The investigators will apply multiple logistic regression and multiple linear regression to ascertain potential associations between maternal iodine status and health and developmental outcomes. Cubic splines will be used to model any nonlinear dose-response associations, making no assumptions regarding any predefined thresholds.
The investigators will also conduct a longitudinal substudy to ascertain how iodine status varies between trimesters (The Hiba study). 200 pregnant women will be recruited at 12 week dating scans and the following collected: baseline characteristics, urine samples for iodide analysis, blood for thyroid stimulating hormone (TSH), free thyroxine (fT4) and triiodothyronine (fT3), thyroglobulin, Glomerular Filtration Rate (GFR) based on serum creatinine, visual inspection of the thyroid using standard methods, dietary intake using a validated online 24h recall tool (myfood24). Data collection will be repeated at 26 and 36 weeks' gestation, and 6, 18 and 30 weeks postpartum. The proposed substudy will clarify how iodine status alters in pregnancy and lactation, and any associated thyroid hormone changes. The investigators will identify key sources of iodine in the diet and ascertain dietary patterns associated with different iodine status. To compare results to a more nationally representative sample, spot urines will be analysed from approximately 650 women in the SCOPE birth-cohort (London, Leeds and Manchester).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Born in Bradford cohort profile is published here: [doi:10.1093/ije/dys112] All women booked for delivery at the Bradford Royal Infirmary at 26-28 weeks gestation. All of the recruited women who provided urine samples are included in our Born in Bradford analysis. The Hiba longitudinal study replicates this process, but at the 12 week dating scan.
Key inclusion criteria (6 listed)
- Female (Both Born in Bradford and Hiba longitudinal cohorts)
- Able to provide informed consent (Both Born in Bradford and Hiba longitudinal cohorts)
- Confirmed pregnant at 26-28 week Oral Glucose Tolerance Test (OGTT) (Born in Bradford cohort)
- Confirmed 9-15 weeks pregnant at 12 week dating scan (Hiba longitudinal cohort)
- Aged 18-40 years (Hiba longitudinal cohort)
Key exclusion criteria (3 listed)
- Inability to provide informed consent (Both Born in Bradford and Hiba longitudinal cohorts)
- Current or former medical history of thyroid disease (Hiba longitudinal cohort)
- Use of thyroid related medications (Hiba longitudinal cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal iodine statusUrinary iodine concentration during pregnancy at 26 weeks' gestation (Bord in Bradford study) and at 12, 26 and 36 weeks' gestation, 6, 18 and 30 weeks postpartum (Hiba longitudinal study). This is primarily in the form of Iodine to Creatinine ratio, to take spot urine volume into account. There is no intervention in this observational study. | Other | – |
Primary outcome
Born in Bradford: Early Years Foundation Stage (EYFS) profiles
Time frame: Ages 3 to 5
The EYFS average points total over 17 domains (score range 17 to 41) and summarised using achievement of Good Level of Development (GLD) (binary).
16 secondary outcomes
Born in Bradford: Key Stage 1 (KS1) educational outcomes
Time frame: Ages 5 to 8
Born in Bradford: Letter identification
Time frame: Ages 3 to 5
Born in Bradford: Receptive vocabulary
Time frame: Ages 3 to 5
Born in Bradford: Social functioning
Time frame: Ages 3 to 5
Born in Bradford: Fine motor skills
Time frame: Ages 3 to 5
Born in Bradford: Birth weight centile
Time frame: At birth
Born in Bradford: Apgar score
Time frame: At 1 minute and 5 minutes after birth.
Born in Bradford: Diagnosis of autism
Time frame: Up to age 11.
Born in Bradford: Diagnosis of attention deficit hyperactivity disorder (ADHD)
Time frame: Up to age 11.
Hiba longitudinal study: Urinary iodine status
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroid stimulating hormone (TSH)
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: triiodothyronine (fT3)
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: free thyroxine (fT4)
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroglobulin
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: thyroid size
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Hiba longitudinal cohort: maternal dietary iodine intake (micrograms)
Time frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Results publication: PubMed 30791590Snart CJP, Keeble C, Taylor E, Cade JE, Stewart PM, Zimmermann M, Reid S, Threapleton DE, Poston L, Myers JE, Simpson NAB, Greenwood DC, Hardie LJ. Maternal Iodine Status and Associations with Birth Outcomes in Three Major Cities in the United Kingdom. Nutrients. 2019 Feb 20;11(2):441. doi: 10.3390/nu11020441.
- Results publication: PubMed 32522280Snart CJP, Threapleton DE, Keeble C, Taylor E, Waiblinger D, Reid S, Alwan NA, Mason D, Azad R, Cade JE, Simpson NAB, Meadows S, McKillion A, Santorelli G, Waterman AH, Zimmermann M, Stewart PM, Wright J, Mon-Williams M, Greenwood DC, Hardie LJ. Maternal iodine status, intrauterine growth, birth outcomes and congenital anomalies in a UK birth cohort. BMC Med. 2020 Jun 11;18(1):132. doi: 10.1186/s12916-020-01602-0.
- Results publication: PubMed 32870514Threapleton DE, Snart CJP, Keeble C, Waterman AH, Taylor E, Mason D, Reid S, Azad R, Hill LJB, Meadows S, McKillion A, Alwan NA, Cade JE, Simpson NAB, Stewart PM, Zimmermann M, Wright J, Waiblinger D, Mon-Williams M, Hardie LJ, Greenwood DC. Maternal iodine status in a multi-ethnic UK birth cohort: Associations with child cognitive and educational development. Paediatr Perinat Epidemiol. 2021 Mar;35(2):236-246. doi: 10.1111/ppe.12719. Epub 2020 Sep 1.
- Results publication: PubMed 33466826Threapleton DE, Waiblinger D, Snart CJP, Taylor E, Keeble C, Ashraf S, Bi S, Ajjan R, Azad R, Hancock N, Mason D, Reid S, Cromie KJ, Alwan NA, Zimmermann M, Stewart PM, Simpson NAB, Wright J, Cade JE, Hardie LJ, Greenwood DC. Prenatal and Postpartum Maternal Iodide Intake from Diet and Supplements, Urinary Iodine and Thyroid Hormone Concentrations in a Region of the United Kingdom with Mild-to-Moderate Iodine Deficiency. Nutrients. 2021 Jan 14;13(1):230. doi: 10.3390/nu13010230.
- Results publication: PubMed 33276760Cromie KJ, Threapleton DE, Snart CJP, Taylor E, Mason D, Wright B, Kelly B, Reid S, Azad R, Keeble C, Waterman AH, Meadows S, McKillion A, Alwan NA, Cade JE, Simpson NAB, Stewart PM, Zimmermann M, Wright J, Waiblinger D, Mon-Williams M, Hardie LJ, Greenwood DC. Maternal iodine status in a multi-ethnic UK birth cohort: associations with autism spectrum disorder. BMC Pediatr. 2020 Dec 5;20(1):544. doi: 10.1186/s12887-020-02440-y.
- Individual participant dataSharing planned: Yes. Born in Bradford welcomes collaboration with other researchers. The BiB website has details of how to submit expressions of interest and has short proformas for these. All suggestions will be reviewed by the BiB Executive Group on a monthly basis, and we aim to get back to potential collaborators within 8 weeks.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren C Greenwood, PhD principal investigator
University of Leeds
Laura J Hardie, PhD principal investigator
University of Leeds
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Developmental Delay and Birth Weight, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Born in Bradford: Early Years Foundation Stage (EYFS) profiles (time frame: Ages 3 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03552341, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.