Iodine Status in PregnancyIOMUMNCT04010708
Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
An observational study of Iodine Status in Pregnancy and Iodine Deficiency, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Status in Pregnancy, Iodine Deficiency
- What is being tested?
- Urinary Iodine Concentration Measurement
- How many people
- 485 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Apr 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Portuguese pregnant women
Who may be able to join
- Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.
Who cannot join
- Use of Levothyroxine.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Medicine of the University of Porto
Porto, 4200-319
About this study
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.
- Conditions
- Iodine Status in Pregnancy, Iodine Deficiency
- Being tested
- Urinary Iodine Concentration Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary Iodine Concentration MeasurementDiagnostic test
UIC
| Study group | Role | What they receive |
|---|---|---|
| IOMUM | Pregnant women Receives: Diagnostic Test: Urinary Iodine Concentration Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st trimester urinary iodine concentration
Median urinary iodine concentration at 1st trimester of gestation
Measured: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Rate of compliance to iodine supplementation guideline
Rate of compliance to iodine supplementation guideline at 1st trimester of gestation
Measured: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Secondary outcomes (5)
Change in median iodine-to-creatinine ratio
Change in median iodine-to-creatinine ratio between 1st and 3rd trimesters of gestation
Measured: Up to 31 weeks
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.
Measured: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Maternal median thyroglobulin
Maternal median thyroglobulin at 3rd trimester of gestation
Measured: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
1st trimester mean sodium excretion
Mean sodium excretion at 1st trimester of gestation
Measured: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
3rd trimester mean sodium excretion
Mean sodium excretion at 3rd trimester of gestation
Measured: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start17 Apr 2018
- Primary completion30 Sep 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iodine Status in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School, Centro Hospitalar De São João, E.P.E., Hospital de Braga, Centro de Investigação em Tecnologias e Serviços de Saúde
- Responsible party
- Sponsor
- Investigators
- Elisa Keating, PhD, Principal investigator, Center for Health Technology and Services ResearchConceição Calhau, PhD, Principal investigator, Center for Health Technology and Services Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010708
- Sponsor's protocol ID
- IOMUM
- Acronym
- IOMUM
- Status last verified
- Jul 2019
- First submitted
- 3 Aug 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35635644
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Status Monitoring in PortUguese Pregnant woMen: Impact of Supplementation
- ClinicalTrials.gov ID
- NCT04010708
- Acronym / sponsor ID
- IOMUM / IOMUM
- Conditions
- Iodine Status in Pregnancy, Iodine Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- NOVA Medical School, Centro Hospitalar De São João, E.P.E., Hospital de Braga, Centro de Investigação em Tecnologias e Serviços de Saúde
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOMUM | – | Diagnostic Test: Urinary Iodine Concentration MeasurementPregnant women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Portuguese pregnant women
Key inclusion criteria (1 listed)
- Pregnant women attending the 1st trimester fetal ultrasound scan, from the 10th to the 13th gestational week.
Key exclusion criteria (1 listed)
- Use of Levothyroxine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary Iodine Concentration MeasurementUIC | Diagnostic test | IOMUM |
Primary outcome
1st trimester urinary iodine concentration
Time frame: 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
Time frame: 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
5 secondary outcomes
Change in median iodine-to-creatinine ratio
Time frame: Up to 31 weeks
Proportion of pregnant women with insufficient, adequate or excessive iodine intake
Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
Maternal median thyroglobulin
Time frame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
1st trimester mean sodium excretion
Time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)
3rd trimester mean sodium excretion
Time frame: Between gestational weeks 35 and 41 (one timepoint collection - Timepoint 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 35635644Matta 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Keating, PhD principal investigator
Center for Health Technology and Services Research
Conceição Calhau, PhD principal investigator
Center for Health Technology and Services Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Status in Pregnancy and Iodine Deficiency, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st trimester urinary iodine concentration (time frame: Between gestational weeks 10 and 13 plus 6 days (one timepoint collection - Timepoint 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.