Preconception Maternal Iodine Status and Offspring Cognitive Function:

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Other: Exposure is maternal iodine

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 Type: Observational
• Enrollment (Actual): 12583

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • MRC Lifecourse Epidemiology Unit, University of Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Offspring of women recruited to the Southampton Women's Survey
• Aged 6-7 years at time of measurement

Exclusion Criteria:

• Mother had not provided urine sample before conception of the child

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Age 6-7 years

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Study Director: Hazel M Inskip, PhD, Deputy Director

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 1998
• Primary Completion (Actual): December 29, 2014
• Study Completion (Actual): December 29, 2014

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Iodine*CogFn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be available once confidentiality arrangements are in place. There is no time restriction.
• IPD Sharing Access Criteria: See website below.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No