## Protocol Section
### Identification Module
**NCT ID:** NCT06412744

**Acronym:** JOZO

**Brief Title:** 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?

#### Organization Study ID Info
**ID:** NL70677.068.19
#### Organization
**Class:** OTHER
**Full Name:** Maastricht University Medical Center
#### Secondary ID Infos
**Domain:** NL trial register (NTR)
**ID:** NL8297
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-10-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-16
**Study First Submit QC Date:** 2024-05-08
**Why Stopped:** Difficulties finding participants
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** National Institute for Public Health and the Environment (RIVM)

#### Lead Sponsor

**Class:** OTHER

**Name:** Maastricht University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 (1, 2). 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 (3). Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining (4). 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)(3). 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 (5-11). Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here we propose 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. We hypothesize that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

### Conditions Module

**Conditions:**

- Pregnancy Related

- Healthy

### Design Module

#### Bio Spec

**Description:** Blood (only plasma and serum is stored) Urine

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 43

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** No intervention, all participants undergo the same measurements

**Label:** Total cohort

### Outcomes Module

#### Primary Outcomes

**Description:** Median urinary iodine excretion (µg/d)

**Measure:** Median urinary iodine excretion (µg/d)

**Time Frame:** At baseline measurement

#### Secondary Outcomes

**Description:** Thyroglobulin and thyroglobulin antibody concentrations in blood serum

**Measure:** Thyroglobulin and thyroglobulin antibody concentrations in blood serum

**Time Frame:** At baseline measurement

**Description:** Creatinin concentration in urine

**Measure:** Creatinin concentration in urine

**Time Frame:** At baseline measurement

**Description:** Urinary volume

**Measure:** Urinary volume

**Time Frame:** At baseline measurement

**Description:** Smoking status (smoking is interfering with iodine metabolism) Yes/no

**Measure:** Smoking status (smoking is interfering with iodine metabolism)

**Time Frame:** At baseline measurement

**Description:** Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)

**Measure:** Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)

**Time Frame:** At baseline measurement

**Description:** Nutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq

**Measure:** Nutritional intake specifically related to iodine intake (questionnaire)

**Time Frame:** At baseline measurement

**Description:** Intake other relevant micronutrients for pregnant

**Measure:** Intake other relevant micronutrients for pregnant

**Time Frame:** At baseline measurement

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Maastricht

**Country:** Netherlands

**Facility:** Maastricht UMC+

**State:** Limburg

**Zip:** 6225 HX

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
