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Trials / Completed

CompletedNCT03322163

Preconception Maternal Iodine Status and Offspring Cognitive Function:

Preconception Maternal Iodine Status and Offspring Cognitive Function: Longitudinal Analyses in the Southampton Women's Survey

Status
Completed
Phase
Study type
Observational
Enrollment
12,583 (actual)
Sponsor
University Hospital Southampton NHS Foundation Trust · Academic / Other
Sex
All
Age
6 Years – 7 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERExposure is maternal iodineThe exposure is preconception maternal iodine status There is no intervention in this observational study

Timeline

Start date
1998-04-06
Primary completion
2014-12-29
Completion
2014-12-29
First posted
2017-10-26
Last updated
2017-10-26

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03322163. Inclusion in this directory is not an endorsement.