Iodine Impact on Thyroid Function and Psychomotor Development, Observational Study in the Portuguese Minho Region (IodineMinho)

May 8, 2023 updated by: Joana Almeida Palha, University of Minho

Observational Study on the Impact of Iodine Supplementation on Maternal and Child's Thyroid Hormone Homeostasis and on the Child's Psychomotor Development, in the Portuguese Minho Region (IodineMinho)

Full intellectual capabilities are achieved only if crucial nutrients are present during development. Iodine deficiency is the most common cause of preventable brain harm in infants. Because of its critical need during pregnancy, several countries implemented programs of iodine supplementation in preconception and pregnancy. In 2013, the prevalence of iodine deficiency in Portugal has led health authorities to issue a recommendation for iodine supplementation. This study aims to evaluate the impact of iodine supplementation on maternal and fetal iodine status and thyroid function, obstetric outcomes, quality of breast milk and child psychomotor development. It also intends to evaluate whether the time of iodine supplementation initiation influences all the above-mentioned parameters. The novelty and relevance of this study reside on the number of women/child and on the extent of health parameters that will be evaluated. The information collected will contribute to the detailed characterization of thyroid hormone homeostasis throughout pregnancy and its relationship with iodine supplementation (including time of initiation). The data will provide evidence on whether this iodine supplementation strategy impacted on iodine sufficiency of the mother and the newborns, or if it needs re-evaluation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Iodine is essential for intellectual development. Its deficiency, alone, is the most frequent cause of preventable brain harm in infants. Iodine is required to synthesize thyroid hormones, key components of central nervous system development. Because of its relevance in pregnancy, several countries have implemented iodine supplementation programs in preconception, pregnancy and lactation.

Iodine deficiency has been previously shown in women of childbearing age in Portugal. Because of this, since 2013 the National Health Authorities have recommended supplementing iodine (200 ug/day) in preconception, pregnant and lactating women. However, the latest Cochrane review on the subject does not allow to conclude on whether iodine supplementation strategies implemented to date are efficient. Therefore, this study is of great public health interest.

The objectives are to:

  • Evaluate whether the new policy of recommending iodine supplementation in preconception, throughout pregnancy and during lactation impacted on the prevalence of iodine deficiency in the Minho region of Portugal when compared to the same population before the recommendation.
  • Evaluate whether the time of initiation of iodine supplementation (if any) influences the serum levels of thyroid hormones in the three trimesters of pregnancy.
  • Evaluate whether the serum levels of thyroid hormones in the first trimester of pregnancy predict psychomotor development of the newborn at 12 months of age.

To achieve these aims the investigators will follow: i) 304 women longitudinally, before, during the three trimesters of pregnancy (primary care Health Centres), at delivery and three months after delivery, ii) their children at birth, 3 and 12 months of age; ii) perform a detailed evaluation of parameters of thyroid function (mother and child) and of psychomotor development of the newborns.

Investigators expect to provide detailed characterization of thyroid hormone homeostasis before and throughout pregnancy, their relation with iodine supplementation (and its timing of administration, if any) and with thyroid hormone parameters and psychomotor development of the newborn.

With 6 years passed since the beginning of recommendation on iodine supplementation, this is an appropriate time to assess its effectiveness. The high number of samples and parameters to analyze make this a high-power study to support public health policies.

Study Type

Observational

Enrollment (Anticipated)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women from community health centers who intend to become pregnant or become pregnant and intend to delivery in the Hospital de Braga.

Description

Inclusion Criteria:

  • Women of who intend to become pregnant or are pregnant, able to read, write and provide informed consent

Exclusion Criteria:

  • Women transferred from outside the study health centres during pregnancy and women taking iodine supplementation before recruitment.
  • Women not intending to deliver at Hospital de Braga.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant and pregnant to be on iodine supplementation
Women in preconception, pregnant and lactating, receiving iodine supplementation
Dietary supplement: Iodine supplementation
Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
Pregnant and pregnant to be not on iodine supplementation
Women in preconception, pregnant or lactating, not receiving iodine supplementation
Women of childbearing age
Women of childbearing age not planning to become pregnant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho region
Time Frame: At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.
Urinary iodine.
At baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.
Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancy
Time Frame: First trimester of pregnancy
Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-thyroperoxidase), urinary iodine.
First trimester of pregnancy
Bayley scale assessed psychomotor development at one year of age
Time Frame: One year of age
Bayley psychomotor development scale
One year of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancy
Time Frame: Serum thyroid hormones and urinary iodine before iodine supplementation (if any), 1st, 2nd, 3rd trimesters of pregnancy, after delivery. Thyroid ultrasound at baseline, 3rd trimester and 3 months after delivery.
Serum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-peroxidase), urinary iodine, thyroid ultrasound.
Serum thyroid hormones and urinary iodine before iodine supplementation (if any), 1st, 2nd, 3rd trimesters of pregnancy, after delivery. Thyroid ultrasound at baseline, 3rd trimester and 3 months after delivery.
Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newborns
Time Frame: One to 3 days of age (if full term babies), 1 to 3 days and 4th week of age (in premature and low birth weight babies).
Serum thyroid hormones (TSH and eventually total and free thyroxine as retrieved from the neonatal newborn screening) and urinary iodine.
One to 3 days of age (if full term babies), 1 to 3 days and 4th week of age (in premature and low birth weight babies).
Iodine and energy composition of human milk 3 months after delivery
Time Frame: Three months after delivery
Iodine and energy composition (total proteins, lipids and carbohydrates).
Three months after delivery
Fetal heart rate and thyroid volume at age 3 months
Time Frame: Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.
Fetal cardiotocography and thyroid ultrasound.
Fetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

Hospital de Braga
Administração Regional de Saúde do Norte, Portugal
Clinical Academic Center (2CA-Braga)
Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal

Investigators

  • Principal Investigator: Joana A Palha, PhD, School of Medicine, University of Minho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Anticipated)

January 10, 2024

Study Completion (Anticipated)

January 10, 2025

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMinho-IodineMinho
  • U1111-1247-2293 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data that underlie results in a publication.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

Data will be provided for collaborative research purposes and for health authorities for public health recommendations. The Principal Investigator, research team and institution directive board will review the requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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