Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Iodine Deficiency Clinical Trial

— IOMUM  

Official title:

Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010708
• Other study ID #: IOMUM
• Status: Completed
• Start date: April 17, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2019
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: February 28, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Use of Levothyroxine.

Related Conditions & MeSH terms

• Iodine Deficiency
• Iodine Status in Pregnancy

Intervention

Diagnostic Test:
• Urinary Iodine Concentration Measurement
UIC

Locations

Country	Name	City	State
Portugal	Faculty of Medicine of the University of Porto	Porto

Sponsors (6)

Lead Sponsor	Collaborator
Universidade do Porto	Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Centro Hospitalar De São João, E.P.E., Faculty of Medicine (FMUP), Hospital de Braga, NOVA Medical School

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st trimester urinary iodine concentration	Median urinary iodine concentration at 1st trimester of gestation	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Primary	Rate of compliance to iodine supplementation guideline	Rate of compliance to iodine supplementation guideline at 1st trimester of gestation	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Secondary	Change in median iodine-to-creatinine ratio	Change in median iodine-to-creatinine ratio between 1st and 3rd trimesters of gestation	Up to 31 weeks
Secondary	Proportion of pregnant women with insufficient, adequate or excessive iodine intake	Classification of pregnant women by urinary iodine concentration levels according to WHO criteria (insufficient, adequate or excessive iodine intake) at 1st trimester of gestation.	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Secondary	Maternal median thyroglobulin	Maternal median thyroglobulin at 3rd trimester of gestation	Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
Secondary	1st trimester mean sodium excretion	Mean sodium excretion at 1st trimester of gestation	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Secondary	3rd trimester mean sodium excretion	Mean sodium excretion at 3rd trimester of gestation	Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)