Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

Thyroid; Functional Disturbance Clinical Trial

Official title:

Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927119
• Other study ID #: GRAV-TG
• Status: Completed
• Phase: N/A
• First received: October 3, 2016
• Last updated: October 5, 2016
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: University of Debrecen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Public Health and Medical Officer Service
• Study type: Observational

Clinical Trial Summary

The purpose of the investigation is to assess iodine status of pregnant women at week 16 of gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The investigators aim to assess whether pre-gestational initiation of iodine supplementation is more advantageous in comparison to supplementation start at the time of pregnancy detection.

Description:

Mild iodine deficiency is still a public health issue in many industrialized countries, especially during pregnancy. During the last decade there was no monitoring of the iodine status in pregnancy in Hungary.

Since urinary iodine concentration (UIC) only reflects recent iodine intake and carries limited information on individual existing iodine stores, another biomarker e.g. measurement of serum thyroglobulin concentration, would be useful to gain comprehensive information. In the present study, the purpose of the investigation is to compare UIC, UIC normalized to creatinine concentration and serum thyroglobulin as biomarkers of iodine supply in pregnant women in a geographical region where previously iodine deficiency had been found.

UIC, serum thyroglobulin level and thyroid function are measured, and information about iodine supplementation and smoking before and during pregnancy are recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy pregnant women at week 16 of gestation

Exclusion Criteria:

• thyroid disease

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dietary Iodine Deficiency
• Pathologic Processes
• Thyroid; Functional Disturbance

Intervention

Dietary Supplement:
• iodine
= 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Debrecen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary iodine concentration	Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration	At subject enrollment	No
Primary	Serum thyroglobulin concentration	Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay	At subject enrollment	No
Secondary	Serum thyroid stimulating hormone concentration	Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay	At subject enrollment	No
Secondary	Serum free thyroxine concentration	Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay	At subject enrollment	No
Secondary	Serum free triiodothyronine concentration	Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay	At subject enrollment	No
Secondary	Serum anti-thyroglobulin autoantibody concentration	Measurement of serum anti-thyroglobulin autoantibody (TgAb) concentration by radioimmunoassay (women with TgAb concentration above 60 IU/L are considered TgAb positive)	At subject enrollment	No