Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

Completed

• Conditions: Dietary Iodine Deficiency; Thyroid; Functional Disturbance
• Interventions: Dietary Supplement: iodine

• Registration Number: NCT02927119
• Lead Sponsor: University of Debrecen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-05
• Last Update Submitted: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 189

Inclusion Criteria

• healthy pregnant women at week 16 of gestation

Exclusion Criteria

• thyroid disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Users	iodine	Pregnant women who had taken dietary iodine supplement before and/or during pregnancy.

Primary Outcome Measures

Name	Time	Method
Urinary iodine concentration	At subject enrollment	Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration
Serum thyroglobulin concentration	At subject enrollment	Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay

Secondary Outcome Measures

Name	Time	Method
Serum thyroid stimulating hormone concentration	At subject enrollment	Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay
Serum anti-thyroglobulin autoantibody concentration	At subject enrollment	Measurement of serum anti-thyroglobulin autoantibody (TgAb) concentration by radioimmunoassay (women with TgAb concentration above 60 IU/L are considered TgAb positive)
Serum free triiodothyronine concentration	At subject enrollment	Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay
Serum free thyroxine concentration	At subject enrollment	Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay