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

NCT04288531 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 304

Last updated 2024-11-15

No results posted yet for this 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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Iodine supplementation

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

Sponsors & Collaborators

  • Instituto Nacional de Saúde Dr Ricardo Jorge, Portugal

    collaborator UNKNOWN
  • Clinical Academic Center (2CA-Braga)

    collaborator OTHER
  • Hospital de Braga

    collaborator OTHER
  • Administração Regional de Saúde do Norte, Portugal

    collaborator OTHER
  • University of Minho

    lead OTHER

Principal Investigators

  • Joana A Palha, PhD · School of Medicine, University of Minho

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2024-01-10
Completion
2026-01-10

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288531 on ClinicalTrials.gov