Pregnancy RelatedJOZONCT06412744
Determination of the Iodine Status in Pregnant Women in the Netherlands.
An observational study of Pregnancy Related and Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Study to determine iodine status in dutch pregnant women Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Healthy
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2020to 1 May 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands
Who may be able to join
- Female
- 18-45y old
- in first 16 weeks of pregnancy
- pregnant of singleton
Who cannot join
- Thyroid-disease or any other metabolic disease
- kidney disease
- twin-pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?
Study to determine iodine status in dutch pregnant women
Read the detailed description
Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.
- Conditions
- Pregnancy Related, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total cohort | No intervention, all participants undergo the same measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median urinary iodine excretion (µg/d)
Median urinary iodine excretion (µg/d)
Measured: At baseline measurement
Secondary outcomes (7)
Thyroglobulin and thyroglobulin antibody concentrations in blood serum
Thyroglobulin and thyroglobulin antibody concentrations in blood serum
Measured: At baseline measurement
Creatinin concentration in urine
Creatinin concentration in urine
Measured: At baseline measurement
Urinary volume
Urinary volume
Measured: At baseline measurement
Smoking status (smoking is interfering with iodine metabolism)
Smoking status (smoking is interfering with iodine metabolism) Yes/no
Measured: At baseline measurement
Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)
Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)
Measured: At baseline measurement
Nutritional intake specifically related to iodine intake (questionnaire)
Nutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq
Measured: At baseline measurement
Intake other relevant micronutrients for pregnant
Intake other relevant micronutrients for pregnant
Measured: At baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start6 Oct 2020
- Primary completion1 May 2024
- Study completion1 May 2024
Why it stopped: Difficulties finding participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412744
- Sponsor's protocol ID
- NL70677.068.19
- Other IDs
- NL8297
- Acronym
- JOZO
- Status last verified
- May 2024
- First submitted
- 16 Dec 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?
- ClinicalTrials.gov ID
- NCT06412744
- Acronym / sponsor ID
- JOZO / NL70677.068.19
- Conditions
- Pregnancy Related, Healthy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties finding participants
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 14 May 2024 (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.
Study to determine iodine status in dutch pregnant women
Detailed description
Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total cohort | – | –No intervention, all participants undergo the same measurements |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands
Key inclusion criteria (4 listed)
- Female
- 18-45y old
- in first 16 weeks of pregnancy
- pregnant of singleton
Key exclusion criteria (3 listed)
- Thyroid-disease or any other metabolic disease
- kidney disease
- twin-pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median urinary iodine excretion (µg/d)
Time frame: At baseline measurement
Median urinary iodine excretion (µg/d)
7 secondary outcomes
Thyroglobulin and thyroglobulin antibody concentrations in blood serum
Time frame: At baseline measurement
Creatinin concentration in urine
Time frame: At baseline measurement
Urinary volume
Time frame: At baseline measurement
Smoking status (smoking is interfering with iodine metabolism)
Time frame: At baseline measurement
Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)
Time frame: At baseline measurement
Nutritional intake specifically related to iodine intake (questionnaire)
Time frame: At baseline measurement
Intake other relevant micronutrients for pregnant
Time frame: At baseline measurement
Results and safety
The study was stopped early (reason given: Difficulties finding participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnancy Related and Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Jun 2024. 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 Netherlands. 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 was stopped early (reason given: Difficulties finding participants). Results are not available in the source record.
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?
Median urinary iodine excretion (µg/d) (time frame: At baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2024.