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Completed

NCT Number: NCT02927119

Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

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.

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Key information

Conditions

Dietary Iodine Deficiency Endocrine System Diseases Thyroid Diseases Thyroid; Functional Disturbance

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy pregnant women at week 16 of gestation

Exclusion criteria

  • thyroid disease

Treatment and study plan

Iodine

Dietary Supplement

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

Primary outcomes

  1. Urinary iodine concentration

    Time frame: At subject enrollment

    Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration

  2. Serum thyroglobulin concentration

    Time frame: At subject enrollment

    Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay

Secondary outcomes

  1. Serum thyroid stimulating hormone concentration

    Time frame: At subject enrollment

    Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay

  2. Serum free thyroxine concentration

    Time frame: At subject enrollment

    Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay

  3. Serum free triiodothyronine concentration

    Time frame: At subject enrollment

    Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2016
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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