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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927119
Other study ID # GRAV-TG
Secondary ID
Status Completed
Phase N/A
First received October 3, 2016
Last updated October 5, 2016
Start date August 2014
Est. completion date December 2014

Study information

Verified date October 2016
Source University of Debrecen
Contact n/a
Is FDA regulated No
Health authority Hungary: National Public Health and Medical Officer Service
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy pregnant women at week 16 of gestation

Exclusion Criteria:

- thyroid disease

Study Design

Time Perspective: Retrospective


Intervention

Dietary Supplement:
iodine
= 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Debrecen

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary iodine concentration Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration At subject enrollment No
Primary Serum thyroglobulin concentration Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay At subject enrollment No
Secondary Serum thyroid stimulating hormone concentration Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay At subject enrollment No
Secondary Serum free thyroxine concentration Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay At subject enrollment No
Secondary Serum free triiodothyronine concentration Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay At subject enrollment No
Secondary 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 No
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