NCT06412744

Brief Summary

Study to determine iodine status in dutch pregnant women

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

June 11, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

December 16, 2022

Last Update Submit

June 10, 2024

Conditions

Pregnancy RelatedHealthy

Outcome Measures

Primary Outcomes (1)

  • Median urinary iodine excretion (µg/d)

    Median urinary iodine excretion (µg/d)

    At baseline measurement

Secondary Outcomes (7)

  • Thyroglobulin and thyroglobulin antibody concentrations in blood serum

    At baseline measurement

  • Creatinin concentration in urine

    At baseline measurement

  • Urinary volume

    At baseline measurement

  • Smoking status (smoking is interfering with iodine metabolism)

    At baseline measurement

  • Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)

    At baseline measurement

  • +2 more secondary outcomes

Study Arms (1)

Total cohort

No intervention, all participants undergo the same measurements

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy pregnant women, under 16 weeks of gestational age living in the Netherlands

You may qualify if:

  • Female
  • y old
  • in first 16 weeks of pregnancy
  • pregnant of singleton

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6225 HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (only plasma and serum is stored) Urine

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

May 14, 2024

Study Start

October 6, 2020

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

June 11, 2024

Record last verified: 2024-05

Locations

NL(1)