Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation

Completed

• Conditions: Iodine Status in Pregnancy; Iodine Deficiency
• Interventions: Diagnostic Test: Urinary Iodine Concentration Measurement

• Registration Number: NCT04010708
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2018-08-03
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-08
• Primary Completion: 2020-09-30
• Study Completion: 2021-02-28
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 485

Inclusion Criteria

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

Exclusion Criteria

• Use of Levothyroxine.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IOMUM	Urinary Iodine Concentration Measurement	Pregnant women

Primary Outcome Measures

Name	Time	Method
1st trimester urinary iodine concentration	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)	Median urinary iodine concentration at 1st trimester of gestation
Rate of compliance to iodine supplementation guideline	Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)	Rate of compliance to iodine supplementation guideline at 1st trimester of gestation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine of the University of Porto; 🇵🇹 Porto, Portugal