Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

NCT ID: NCT02927119

Last Updated: 2016-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 189 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Dietary Iodine Deficiency; Thyroid; Functional Disturbance

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Non-users

Pregnant women who had not taken dietary iodine supplement before and during pregnancy.

No interventions assigned to this group

Users

Pregnant women who had taken dietary iodine supplement before and/or during pregnancy.

iodine

Intervention Type: DIETARY_SUPPLEMENT

≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment

Interventions

iodine

≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• healthy pregnant women at week 16 of gestation

Exclusion Criteria

• thyroid disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Debrecen

OTHER

Sponsor Role: lead

Responsible Party

Endre V Nagy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Endre V Nagy, MD, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

University of Debrecen

Other Identifiers

GRAV-TG

Identifier Type: -

Identifier Source: org_study_id