Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid; Functional Disturbance; Dietary Iodine Deficiency
• Intervention / Treatment: Dietary supplement: iodine

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 Type: Observational
• Enrollment (Actual): 189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women at week 16 of gestation living in Debrecen and its sorroundings

Description

Inclusion Criteria:

• healthy pregnant women at week 16 of gestation

Exclusion Criteria:

• thyroid disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-users; Pregnant women who had not taken dietary iodine supplement before and during pregnancy.
Users; Pregnant women who had taken dietary iodine supplement before and/or during pregnancy.	Dietary supplement: iodine; ≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum thyroid stimulating hormone concentration	Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay	At subject enrollment
Serum free thyroxine concentration	Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay	At subject enrollment
Serum free triiodothyronine concentration	Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay	At subject enrollment
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

Collaborators and Investigators

• Sponsor: University of Debrecen
• Investigators: Principal Investigator: Endre V Nagy, MD, PhD, DSc, University of Debrecen

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy; iodine; thyroglobulin
• Other Study ID Numbers: GRAV-TG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED