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

Last updated: November 13, 2024
Sponsor: University of Minho
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Thyroid Disease

Female Hormonal Deficiencies/abnormalities

Hormone Deficiencies

Treatment

Iodine supplementation

Clinical Study ID

NCT04288531
UMinho-IodineMinho
U1111-1247-2293
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Women transferred from outside the study health centres during pregnancy and womentaking iodine supplementation before recruitment.

  • Women not intending to deliver at Hospital de Braga.

Study Design

Total Participants: 304
Treatment Group(s): 1
Primary Treatment: Iodine supplementation
Phase:
Study Start date:
January 10, 2020
Estimated Completion Date:
January 10, 2026

Study 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.

Connect with a study center

  • Usf + Carandá

    Braga, 4710-406
    Portugal

    Site Not Available

  • Usf Bracara Augusta

    Braga, 4715-213
    Portugal

    Site Not Available

  • Usf Braga Norte

    Braga, 4700-395
    Portugal

    Site Not Available

  • Usf Do Minho

    Braga, 4715-402
    Portugal

    Site Not Available

  • Usf Gualtar

    Braga, 4710-078
    Portugal

    Site Not Available

  • Usf Manuel Rocha Peixoto

    Braga, 4715-123
    Portugal

    Site Not Available

  • Usf Maxisaude

    Braga, 4700-036
    Portugal

    Site Not Available

  • Usf Ruães

    Braga, 4700-565
    Portugal

    Site Not Available

  • Usf S. João de Braga

    Braga, 4715-402
    Portugal

    Site Not Available

  • Usf S. Lourenço

    Braga, 4705-414
    Portugal

    Site Not Available

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