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Determination of the Iodine Status in Pregnant Women in the Netherlands.

Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06412744
Acronym
JOZO
Enrollment
43
Registered
2024-05-14
Start date
2020-10-06
Completion date
2024-05-01
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Pregnancy Related

Brief summary

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.

Interventions

None listed

Sponsors

National Institute for Public Health and the Environment (RIVM)
CollaboratorOTHER_GOV
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Female * 18-45y old * in first 16 weeks of pregnancy * pregnant of singleton

Exclusion criteria

* Thyroid-disease or any other metabolic disease * kidney disease * twin-pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Median urinary iodine excretion (µg/d)At baseline measurementMedian urinary iodine excretion (µg/d)

Secondary

MeasureTime frameDescription
Creatinin concentration in urineAt baseline measurementCreatinin concentration in urine
Urinary volumeAt baseline measurementUrinary volume
Smoking status (smoking is interfering with iodine metabolism)At baseline measurementSmoking status (smoking is interfering with iodine metabolism) Yes/no
Thyroglobulin and thyroglobulin antibody concentrations in blood serumAt baseline measurementThyroglobulin and thyroglobulin antibody concentrations in blood serum
Nutritional intake specifically related to iodine intake (questionnaire)At baseline measurementNutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq
Intake other relevant micronutrients for pregnantAt baseline measurementIntake other relevant micronutrients for pregnant
Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)At baseline measurementVegan/Vegetarian y/n (soy is competitive for iodine on thyroid)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026