ClinicalTrials.gov
ClinicalTrials.gov Menu

Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02927119
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Endre V Nagy, University of Debrecen

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.

Condition or disease Intervention/treatment
Dietary Iodine Deficiency Thyroid; Functional Disturbance Dietary Supplement: iodine

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.


Study Type : Observational
Actual Enrollment : 189 participants
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Group/Cohort Intervention/treatment
Non-users
Pregnant women who had not taken dietary iodine supplement before and during pregnancy.
Users
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)


Biospecimen Retention:   Samples Without DNA
serum urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women at week 16 of gestation living in Debrecen and its sorroundings
Criteria

Inclusion Criteria:

  • healthy pregnant women at week 16 of gestation

Exclusion Criteria:

  • thyroid disease

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Debrecen
Investigators
Principal Investigator: Endre V Nagy, MD, PhD, DSc University of Debrecen

Responsible Party: Endre V Nagy, Professor, University of Debrecen
ClinicalTrials.gov Identifier: NCT02927119     History of Changes
Other Study ID Numbers: GRAV-TG
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Endre V Nagy, University of Debrecen:
thyroglobulin
iodine
pregnancy

Additional relevant MeSH terms:
Pathologic Processes
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs