Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

NCT ID: NCT04010708

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-17

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Data from 2007 regarding iodine status among Portuguese pregnant women indicate this is an iodine deficient population group, with only 16.8% presenting adequate urinary iodine values. This may have serious implications for normal cognitive development of the offspring and a concerning socioeconomic impact. In 2013, concerns by the Portuguese Directorate-General of Health lead to the implementation of a public health policy (nº 011/2013) recommending iodine supplementation during pregnancy. IoMum emerges from this context to monitor and update iodine status in Portuguese pregnant women and to evaluate the effectiveness of the above policy by assessing clinical compliance to iodine supplementation and the impact of iodine supplementation in this vulnerable group. IoMum will update data on iodine nutrition in Portuguese pregnant women, promoting political actions towards the elimination of iodine deficiency and thus to the reduction of nutritional, social and economic inequalities.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iodine Status in Pregnancy Iodine Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IOMUM

Pregnant women

Urinary Iodine Concentration Measurement

Intervention Type DIAGNOSTIC_TEST

UIC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urinary Iodine Concentration Measurement

UIC

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.

Exclusion Criteria

* Use of Levothyroxine.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NOVA Medical School

OTHER

Sponsor Role collaborator

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role collaborator

Hospital de Braga

OTHER

Sponsor Role collaborator

Centro de Investigação em Tecnologias e Serviços de Saúde

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisa Keating, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Technology and Services Research

Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Technology and Services Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine of the University of Porto

Porto, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

References

Explore related publications, articles, or registry entries linked to this study.

Matta Coelho C, Guimaraes J, Bracchi I, Xavier Moreira N, Pinheiro C, Ferreira P, Pestana D, Barreiros Mota I, Cortez A, Prucha C, Martins C, Pinto E, Almeida A, Delerue-Matos C, Dias CC, Moreira-Rosario A, Ribeiro de Azevedo LF, Cruz Fernandes V, Ramalho C, Calhau C, Brantsaeter AL, Costa Leite J, Keating E. Noncompliance to iodine supplementation recommendation is a risk factor for iodine insufficiency in Portuguese pregnant women: results from the IoMum cohort. J Endocrinol Invest. 2022 Oct;45(10):1865-1874. doi: 10.1007/s40618-022-01813-7. Epub 2022 May 30.

Reference Type DERIVED
PMID: 35635644 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IOMUM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Iodine Supplementation in Obesity
NCT01985204 COMPLETED NA