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Iodine Status in Pregnancy and Associated Health Outcomes (Hiba)

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ClinicalTrials.gov Identifier: NCT03552341
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Bradford Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Darren Greenwood, University of Leeds

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.

Condition or disease Intervention/treatment
Cognitive Developmental Delay Birth Weight Other: Maternal iodine status

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Iodine Status and Associated Health Outcomes in British Women During Pregnancy
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine


Intervention Details:
  • Other: Maternal iodine status
    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.


Primary Outcome Measures :
  1. Born in Bradford: Early Years Foundation Stage (EYFS) profiles [ Time Frame: Ages 3 to 5 ]
    The EYFS average points total over 17 domains (score range 17 to 41) and summarised using achievement of Good Level of Development (GLD) (binary).


Secondary Outcome Measures :
  1. Born in Bradford: Key Stage 1 (KS1) educational outcomes [ Time Frame: Ages 5 to 8 ]
    Year 1 phonics screening test (score range 0 to 40) and KS1 SATS scores in Reading, Writing, Mathematics and Science (working securely at level 2b or beyond pre-2016 or working at the expected standard or beyond for 2016 onwards, binary) will be presented.

  2. Born in Bradford: Letter identification [ Time Frame: Ages 3 to 5 ]
    Letter identification (standardised)

  3. Born in Bradford: Receptive vocabulary [ Time Frame: Ages 3 to 5 ]
    Receptive vocabulary using the British Picture Vocabulary Scale (BPVS)(standardised)

  4. Born in Bradford: Social functioning [ Time Frame: Ages 3 to 5 ]
    Social functioning using the Strengths and Difficulties Questionnaire (SDQ) total difficulty score and split by domains (e.g. internalising and externalising)

  5. Born in Bradford: Fine motor skills [ Time Frame: Ages 3 to 5 ]
    Fine motor skills using the Clinical Kinematic Assessment Tool (CKAT) overall battery score, along with Tracking, Aiming and Tracing CKAT sub-scores.

  6. Born in Bradford: Birth weight centile [ Time Frame: At birth ]
    The main birth outcome of interest is birth weight centile, calculated using the version 8.0.1 of the Bulk centile calculator provided by the Gestation Network based at the Perinatal Institute for Maternal and Child Health

  7. Born in Bradford: Apgar score [ Time Frame: At 1 minute and 5 minutes after birth. ]
    Apgar score (ordinal).

  8. Born in Bradford: Diagnosis of autism [ Time Frame: Up to age 11. ]
    Confirmed diagnosis of autism based on Read codes in linked General Practitioner records.

  9. Born in Bradford: Diagnosis of attention deficit hyperactivity disorder (ADHD) [ Time Frame: Up to age 11. ]
    Confirmed diagnosis of attention deficit hyperactivity disorder (ADHD) based on Read codes in linked General Practitioner records.

  10. Hiba longitudinal study: Urinary iodine status [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    The main outcome of interest is urinary iodine status (primarily in the form of iodine to creatinine ratio to take account of spot urine volumes) changes during pregnancy and lactation (continuous)

  11. Hiba longitudinal cohort: thyroid stimulating hormone (TSH) [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Changes in thyroid stimulating hormone (TSH) during gestation and lactation.

  12. Hiba longitudinal cohort: triiodothyronine (fT3) [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Changes in triiodothyronine (fT3) during gestation and lactation.

  13. Hiba longitudinal cohort: free thyroxine (fT4) [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Changes in free thyroxine (fT4) during gestation and lactation.

  14. Hiba longitudinal cohort: thyroglobulin [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Changes in thyroglobulin during gestation and lactation.

  15. Hiba longitudinal cohort: thyroid size [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Changes in thyroid size, measured by palpation, using a standard protocol, during gestation and lactation.

  16. Hiba longitudinal cohort: maternal dietary iodine intake (micrograms) [ Time Frame: 12, 26 and 36 weeks' gestation during pregnancy, and 6, 18 and 30 weeks' postpartum. ]
    Identification of highest ranking food items in terms of contribution to iodine in the maternal diet as measured using the myfood24 tool


Other Outcome Measures:
  1. Born in Bradford: length of gestation [ Time Frame: At birth ]
    length of gestation (weeks), presenting pre-term delivery (<37 weeks)

  2. Born in Bradford: congenital anomalies [ Time Frame: At birth ]
    Diagnosis of congenital anomalies from linked congenital anomalies records (binary)

  3. Born in Bradford: childhood growth trajectories [ Time Frame: From 26 weeks gestation, through to age 11 ]
    Childhood growth trajectories (weight in kg)

  4. Born in Bradford: Key Stage 2 (KS2) educational outcomes [ Time Frame: Ages 8 to 11 ]
    Key Stage 2 (KS2) SATS scores in English grammar, punctuation and spelling, English reading, and Mathematics.

  5. Born in Bradford: maternal mental health [ Time Frame: From 26 weeks gestation, through to age 11 ]
    Patient Health Questionnaire 9 (PHQ-9) depression test questionnaire


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552341


Sponsors and Collaborators
University of Leeds
Bradford Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Darren C Greenwood, PhD University of Leeds
Principal Investigator: Laura J Hardie, PhD University of Leeds
  Study Documents (Full-Text)

Documents provided by Darren Greenwood, University of Leeds:
Statistical Analysis Plan  [PDF] November 22, 2018


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Responsible Party: Darren Greenwood, Senior Lecturer in Biostatistics, University of Leeds
ClinicalTrials.gov Identifier: NCT03552341     History of Changes
Other Study ID Numbers: PR-R10-0514-11004
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Born in Bradford welcomes collaboration with other researchers. The BiB website has details of how to submit expressions of interest and has short proformas for these. All suggestions will be reviewed by the BiB Executive Group on a monthly basis, and we aim to get back to potential collaborators within 8 weeks.
Time Frame: Ongoing.
Access Criteria: Submit expressions of interest on a short proforma. All suggestions will be reviewed by the BiB Executive Group.
URL: https://borninbradford.nhs.uk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Darren Greenwood, University of Leeds:
Iodine
Cognitive function
Birth outcomes
Pregnancy
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs