Clinical trial NCT03322163: Preconception Maternal Iodine Status and Offspring Cognitive Function:
Official title: Preconception Maternal Iodine Status and Offspring Cognitive Function: Longitudinal Analyses in the Southampton Women's Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Function
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 12583
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function
timeFrame: Age 6-7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: MRC Lifecourse Epidemiology Unit, University of Southampton
state: Hampshire
Study officials:
affiliation: Deputy Director
name: Hazel M Inskip, PhD
role: STUDY_DIRECTOR
References:
citation: 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.