Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04288531 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: IodineMinho
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 10, 2025 to Jan 10, 2026
    • Site details revised at 10 of 10 sites
    v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Enrollment target: 1000 to 304
    • Study description revised
    • Site contacts updated at 3 of 10 sites
    v5
  4. Minor Site details revised at 2 of 10 sitesv4
  5. Minor Site details revised at 5 of 10 sitesv3
  6. Minor Study description expanded, about 22 wordsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)
Iodine Deficiency, Thyroid, Pregnancy Related, Psychomotor Impairment, Hypothyroidism in Pregnancy, Nutrient Deficiency
Related terms Congenital Hypothyroidism, Psychomotor Disorders, Thyroid Diseases
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov