Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy
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|ClinicalTrials.gov Identifier: NCT02927119|
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment|
|Dietary Iodine Deficiency Thyroid; Functional Disturbance||Dietary Supplement: iodine|
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|
|Actual Enrollment :||189 participants|
|Official Title:||Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Pregnant women who had not taken dietary iodine supplement before and during pregnancy.
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
- Urinary iodine concentration [ Time Frame: At subject enrollment ]Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration
- Serum thyroglobulin concentration [ Time Frame: At subject enrollment ]Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay
- Serum thyroid stimulating hormone concentration [ Time Frame: At subject enrollment ]Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay
- Serum free thyroxine concentration [ Time Frame: At subject enrollment ]Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay
- Serum free triiodothyronine concentration [ Time Frame: At subject enrollment ]Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay
- Serum anti-thyroglobulin autoantibody concentration [ Time Frame: 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)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927119
|Principal Investigator:||Endre V Nagy, MD, PhD, DSc||University of Debrecen|