Cognitive FunctionNCT03322163
Preconception Maternal Iodine Status and Offspring Cognitive Function:
An observational study of Cognitive Function, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Little is known about maternal iodine nutrition before conception and its relation with the child's cognitive function. Using samples and data from the Southampton Women's Survey, iodine measurements from urine collected before the mothers became pregnant will be related to cognitive function measures in the children… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Exposure is maternal iodine
- How many people
- 12,583 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 1998to 29 Dec 2014
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The children are part of a cohort study that recruited their mothers before they were conceived. Women registered with a general practitioner in the Southampton area were recruited at ages 20-34 years when they were not pregnant. Those who subsequently became pregnant were followed through the pregnancy and then the children are being followed-up. This study focuses on iodine measures from the preconception recruitment and the follow-up in their homes of the children aged 6-7 years.
Who may be able to join
- Offspring of women recruited to the Southampton Women's Survey
- Aged 6-7 years at time of measurement
Who cannot join
- Mother had not provided urine sample before conception of the child
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Lifecourse Epidemiology Unit, University of Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Preconception Maternal Iodine Status and Offspring Cognitive Function: Longitudinal Analyses in the Southampton Women's Survey
Little is known about maternal iodine nutrition before conception and its relation with the child's cognitive function. Using samples and data from the Southampton Women's Survey, iodine measurements from urine collected before the mothers became pregnant will be related to cognitive function measures in the children at age 6-7 years.
Read the detailed description
Adverse effects of severe maternal iodine deficiency in pregnancy on fetal brain development are well-established, but the effects of mild or moderate deficiency are not well understood. To date, most studies have examined iodine status in pregnancy; less is known about maternal iodine nutrition before conception, and this study aims to address that gap in information
The Southampton Women's Survey (SWS) is a prospective study of mothers and children, established in 1998. A general population sample of 12,583 non-pregnant women, aged 20-34 years resident in Southampton was recruited (1998-2002). All women were visited at home by a research nurse and characterised in detail, including assessments of diet, lifestyle and body composition. Between 1998 and 2007, 3158 of the SWS women became pregnant, and went on to deliver a live singleton infant. These women were followed up in through pregnancy and their children have been assessed in a number of follow-up studies in infancy and childhood. These have included repeated assessments of diet, anthropometry and body composition, as well as detailed functional measurements at specific ages, and are ongoing.
At the 6-7 year assessment, the children's cognitive function was measured and this is the primary outcome.
Spot urine samples were collected from the SWS women at clinic visits following their initial interviews (median 33 (IQR 15-87) days), in the period before conception. The time of day was recorded for each urine collection. Urine samples were split divided into aliquots on the day of collection. They were frozen and stored at -80⁰oC from the date of collection until being thawed and assayed for iodine and creatinine contents in 2016 by the Trace Element Unit, Southampton General NHS Trust Hospital, Southampton, UK.
- Conditions
- Cognitive Function
- Being tested
- Exposure is maternal iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure is maternal iodineOther
The exposure is preconception maternal iodine status 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.
Cognitive function
Cognitive function assessed using the 2-subtest form of the Wechsler Abbreviated Scale of Intelligence and specific components of executive function (Delayed Matching to Subject (DMS), Spatial Span (SSP) and Intra-Extra Dimensional Set Shift (IED)) from the Cambridge Neuropsychological Test Automated Battery (CANTAB®, Cambridge Cognition, Cambridge, UK)
Measured: Age 6-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start6 Apr 1998
- Primary completion29 Dec 2014
- Study completion29 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies 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
- 12,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazel M Inskip, PhD, Study director, Deputy Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322163
- Sponsor's protocol ID
- Iodine*CogFn
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the whole Southampton Women's Survey are shared with other researchers in a collaborative model. Contact can be made via the website: www.mrc.soton.ac.uk
Publications
Inskip HM, Godfrey KM, Robinson SM, Law CM, Barker DJ, Cooper C; SWS Study Group. Cohort profile: The Southampton Women's Survey. Int J Epidemiol. 2006 Feb;35(1):42-8. doi: 10.1093/ije/dyi202. Epub 2005 Sep 29. No abstract available.
PubMed 16195252
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconception Maternal Iodine Status and Offspring Cognitive Function: Longitudinal Analyses in the Southampton Women's Survey
- ClinicalTrials.gov ID
- NCT03322163
- Acronym / sponsor ID
- Iodine*CogFn
- Conditions
- Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,583 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Apr 1998 (actual)
- Primary completion
- 29 Dec 2014 (actual)
- Study completion
- 29 Dec 2014 (actual)
- First posted
- 26 Oct 2017 (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.
Little is known about maternal iodine nutrition before conception and its relation with the child's cognitive function. Using samples and data from the Southampton Women's Survey, iodine measurements from urine collected before the mothers became pregnant will be related to cognitive function measures in the children at age 6-7 years.
Detailed description
Adverse effects of severe maternal iodine deficiency in pregnancy on fetal brain development are well-established, but the effects of mild or moderate deficiency are not well understood. To date, most studies have examined iodine status in pregnancy; less is known about maternal iodine nutrition before conception, and this study aims to address that gap in information
The Southampton Women's Survey (SWS) is a prospective study of mothers and children, established in 1998. A general population sample of 12,583 non-pregnant women, aged 20-34 years resident in Southampton was recruited (1998-2002). All women were visited at home by a research nurse and characterised in detail, including assessments of diet, lifestyle and body composition. Between 1998 and 2007, 3158 of the SWS women became pregnant, and went on to deliver a live singleton infant. These women were followed up in through pregnancy and their children have been assessed in a number of follow-up studies in infancy and childhood. These have included repeated assessments of diet, anthropometry and body composition, as well as detailed functional measurements at specific ages, and are ongoing.
At the 6-7 year assessment, the children's cognitive function was measured and this is the primary outcome.
Spot urine samples were collected from the SWS women at clinic visits following their initial interviews (median 33 (IQR 15-87) days), in the period before conception. The time of day was recorded for each urine collection. Urine samples were split divided into aliquots on the day of collection. They were frozen and stored at -80⁰oC from the date of collection until being thawed and assayed for iodine and creatinine contents in 2016 by the Trace Element Unit, Southampton General NHS Trust Hospital, Southampton, UK.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The children are part of a cohort study that recruited their mothers before they were conceived. Women registered with a general practitioner in the Southampton area were recruited at ages 20-34 years when they were not pregnant. Those who subsequently became pregnant were followed through the pregnancy and then the children are being followed-up. This study focuses on iodine measures from the preconception recruitment and the follow-up in their homes of the children aged 6-7 years.
Key inclusion criteria (2 listed)
- Offspring of women recruited to the Southampton Women's Survey
- Aged 6-7 years at time of measurement
Key exclusion criteria (1 listed)
- Mother had not provided urine sample before conception of the child
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 |
|---|---|---|
| Exposure is maternal iodineThe exposure is preconception maternal iodine status There is no intervention in this observational study | Other | – |
Primary outcome
Cognitive function
Time frame: Age 6-7 years
Cognitive function assessed using the 2-subtest form of the Wechsler Abbreviated Scale of Intelligence and specific components of executive function (Delayed Matching to Subject (DMS), Spatial Span (SSP) and Intra-Extra Dimensional Set Shift (IED)) from the Cambridge Neuropsychological Test Automated Battery (CANTAB®, Cambridge Cognition, Cambridge, UK)
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 26 Oct 2017.
- Background: PubMed 16195252Inskip HM, Godfrey KM, Robinson SM, Law CM, Barker DJ, Cooper C; SWS Study Group. Cohort profile: The Southampton Women's Survey. Int J Epidemiol. 2006 Feb;35(1):42-8. doi: 10.1093/ije/dyi202. Epub 2005 Sep 29. No abstract available.
- Individual participant dataSharing planned: Yes. Data from the whole Southampton Women's Survey are shared with other researchers in a collaborative model. Contact can be made via the website: www.mrc.soton.ac.uk
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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.
Hazel M Inskip, PhD study director
Deputy Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Function, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 1 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cognitive function (time frame: Age 6-7 years). 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 NCT03322163, which also lists 1 linked publication.
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 26 Oct 2017.