Iodine Status in Pregnancy and Associated Health Outcomes

NCT03552341 | Completed

• 1 other identifier: PR-R10-0514-11004
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cognitive Developmental Delay; Birth Weight

Keywords

Iodine; Cognitive function; Birth outcomes; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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).

  Ages 3 to 5

Secondary Outcomes (16)

• Born in Bradford: Key Stage 1 (KS1) educational outcomes

  Ages 5 to 8

• Born in Bradford: Letter identification

  Ages 3 to 5

• Born in Bradford: Receptive vocabulary

  Ages 3 to 5

• Born in Bradford: Social functioning

  Ages 3 to 5

• Born in Bradford: Fine motor skills

  Ages 3 to 5

Other Outcomes (5)

• Born in Bradford: length of gestation

  At birth

• Born in Bradford: congenital anomalies

  At birth

• Born in Bradford: childhood growth trajectories

  From 26 weeks gestation, through to age 11

Interventions

Maternal iodine status OTHER

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Leeds: lead
• Bradford Teaching Hospitals NHS Foundation Trust: collaborator

Related Publications (5)

• 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.

  PMID: 30791590 RESULT

• Snart 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.

  PMID: 32522280 RESULT

• Threapleton 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.

  PMID: 32870514 RESULT

• Threapleton 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.

  PMID: 33466826 RESULT

• Cromie 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.

  PMID: 33276760 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

7000 urine samples from the Born in Bradford cohort. 200 urine and blood samples during pregnancy and lactation from the Hiba longitudinal cohort.

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Darren C Greenwood, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

• Laura J Hardie, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Biostatistics

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 11, 2018
• Study Start: February 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Ongoing.
• Access Criteria: Submit expressions of interest on a short proforma. All suggestions will be reviewed by the BiB Executive Group.