Clinical trial NCT04010708: Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
Official title: Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Status in Pregnancy
Iodine Deficiency
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: NOVA Medical School
name: Centro Hospitalar De São João, E.P.E.
name: Hospital de Braga
name: Centro de Investigação em Tecnologias e Serviços de Saúde
First posted: 2019-07-08
Enrollment: 485
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Portuguese pregnant women

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Use of Levothyroxine.

Primary outcomes:
measure: 1st trimester urinary iodine concentration
timeFrame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
measure: Rate of compliance to iodine supplementation guideline
timeFrame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Secondary outcomes:
measure: Change in median iodine-to-creatinine ratio
timeFrame: Up to 31 weeks
measure: Proportion of pregnant women with insufficient, adequate or excessive iodine intake
timeFrame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
measure: Maternal median thyroglobulin
timeFrame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
measure: 1st trimester mean sodium excretion
timeFrame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
measure: 3rd trimester mean sodium excretion
timeFrame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine of the University of Porto
Study officials:
affiliation: Center for Health Technology and Services Research
name: Elisa Keating, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Health Technology and Services Research
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.