Clinical trial NCT06412744: Determination of the Iodine Status in Pregnant Women in the Netherlands.
Official title: Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy Related
Healthy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Public Health and the Environment (RIVM)
First posted: 2024-05-14
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median urinary iodine excretion (µg/d)
timeFrame: At baseline measurement
Secondary outcomes:
measure: Thyroglobulin and thyroglobulin antibody concentrations in blood serum
timeFrame: At baseline measurement
measure: Creatinin concentration in urine
timeFrame: At baseline measurement
measure: Urinary volume
timeFrame: At baseline measurement
measure: Smoking status (smoking is interfering with iodine metabolism)
timeFrame: At baseline measurement
measure: Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)
timeFrame: At baseline measurement
measure: Nutritional intake specifically related to iodine intake (questionnaire)
timeFrame: At baseline measurement
measure: Intake other relevant micronutrients for pregnant
timeFrame: At baseline measurement
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
References: