Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412744
Status:
TERMINATED
Last Update Posted:
2024-06-11
First Post:
2022-12-16
Brief Title:
Determination of the Iodine Status in Pregnant Women in the Netherlands
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Determination of the Iodine Status in Pregnant Women in the Netherlands Are Current Iodine Intake Recommendations Still Adequate
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties finding participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JOZO
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 µgday 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 ugd Also in other Western European countries ie Belgium UK North Ireland Sweden Denmark and Austria low median urinary concentrations of iodine 73-124 ugL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8297 | REGISTRY | NL trial register NTR | None |