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Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02927119
Enrollment
189
Registered
2016-10-06
Start date
2014-08-31
Completion date
2014-12-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Iodine Deficiency, Thyroid; Functional Disturbance

Keywords

thyroglobulin, iodine, pregnancy

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.

Interventions

DIETARY_SUPPLEMENTiodine

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

Sponsors

University of Debrecen
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* healthy pregnant women at week 16 of gestation

Exclusion criteria

* thyroid disease

Design outcomes

Primary

MeasureTime frameDescription
Urinary iodine concentrationAt subject enrollmentMeasurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration
Serum thyroglobulin concentrationAt subject enrollmentMeasurement of serum thyroglobulin concentration by chemiluminescent immunoassay

Secondary

MeasureTime frameDescription
Serum thyroid stimulating hormone concentrationAt subject enrollmentMeasurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay
Serum free thyroxine concentrationAt subject enrollmentMeasurement of serum free thyroxine concentration by electrochemiluminescence immunoassay
Serum free triiodothyronine concentrationAt subject enrollmentMeasurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay
Serum anti-thyroglobulin autoantibody concentrationAt subject enrollmentMeasurement of serum anti-thyroglobulin autoantibody (TgAb) concentration by radioimmunoassay (women with TgAb concentration above 60 IU/L are considered TgAb positive)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026