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

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04288531
Acronym
IodineMinho
Enrollment
304
Registered
2020-02-28
Start date
2020-01-10
Completion date
2026-01-10
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism in Pregnancy, Iodine Deficiency, Nutrient Deficiency, Pregnancy Related, Psychomotor Impairment, Thyroid

Keywords

Iodine, Human milk, Maternal health, Nutritional assessment, Thyroid hormones, Pregnancy, Population health, Congenital hypothyroidism, Psychomotor development

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTIodine supplementation

Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.

Sponsors

Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal
CollaboratorUNKNOWN
Clinical Academic Center (2CA-Braga)
CollaboratorOTHER
Hospital de Braga
CollaboratorOTHER
Administração Regional de Saúde do Norte, Portugal
CollaboratorOTHER
University of Minho
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of iodine deficiency in pregnant women and in women of childbearing age in the Minho regionAt baseline in women recruited for pregnancy follow-up and in women in childbearing age not planning to become pregnant.Urinary iodine.
Impact of iodine supplementation on maternal serum parameters of thyroid function and urinary iodine in the first trimester of pregnancyFirst trimester of pregnancySerum thyroid hormones (TSH, total and free T4, total and free T3, thyroxine-binding globulin, human chorionic gonadotropin, thyroglobulin, anti-thyroglobulin, anti-thyroperoxidase), urinary iodine.
Bayley scale assessed psychomotor development at one year of ageOne year of ageBayley psychomotor development scale

Secondary

MeasureTime frameDescription
Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization throughout pregnancySerum 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.
Fetal heart rate and thyroid volume at age 3 monthsFetal cardiotocography at 36-40 weeks of gestation and thyroid ultrasound at 3 months of age.Fetal cardiotocography and thyroid ultrasound.
Serum parameters of thyroid function, urinary iodine and thyroid ultrasound characterization of newbornsOne 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.
Iodine and energy composition of human milk 3 months after deliveryThree months after deliveryIodine and energy composition (total proteins, lipids and carbohydrates).

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026