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

Terminated

• Conditions: Healthy; Pregnancy Related

• Registration Number: NCT06412744
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2022-12-16
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Study First Submitted QC: 2024-05-08
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median urinary iodine excretion (µg/d)	At baseline measurement	Median urinary iodine excretion (µg/d)

Secondary Outcome Measures

Name	Time	Method
Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)	At baseline measurement	Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)
Nutritional intake specifically related to iodine intake (questionnaire)	At baseline measurement	Nutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq
Urinary volume	At baseline measurement	Urinary volume
Smoking status (smoking is interfering with iodine metabolism)	At baseline measurement	Smoking status (smoking is interfering with iodine metabolism) Yes/no
Intake other relevant micronutrients for pregnant	At baseline measurement	Intake other relevant micronutrients for pregnant
Thyroglobulin and thyroglobulin antibody concentrations in blood serum	At baseline measurement	Thyroglobulin and thyroglobulin antibody concentrations in blood serum
Creatinin concentration in urine	At baseline measurement	Creatinin concentration in urine

Trial Locations

Locations (1)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands