Clinical Trial

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

Study acronym: IodineMinho
Active, Not Recruiting
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-02-25; most recent amendment 2024-11-13.
Status change: Recruiting → Active, Not Recruiting 2024-11-13
Trial Details
NCT Number NCT04288531
Lead Sponsor University of Minho
Collaborators: National Health Institute Dr. Ricardo Jorge, Clinical Academic Center (2CA-Braga), Hospital de Braga, Administração Regional de Saúde do Norte, Portugal
Conditions Iodine Deficiency, Thyroid, Pregnancy Related, Psychomotor Impairment, Hypothyroidism in Pregnancy, Nutrient Deficiency
Enrollment 304 participants
Start Date 2020-01-10
Primary Completion 2024-01-10 (estimated)
Study Completion 2026-01-10 (estimated)
Updated on ClinicalTrials.gov 2024-11-15