NCT02927119

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 3, 2016

Last Update Submit

October 5, 2016

Conditions

Dietary Iodine DeficiencyThyroid; Functional Disturbance

Keywords

thyroglobuliniodinepregnancy

Outcome Measures

Primary Outcomes (2)

  • Urinary iodine concentration

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

    At subject enrollment

  • Serum thyroglobulin concentration

    Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay

    At subject enrollment

Secondary Outcomes (4)

  • Serum thyroid stimulating hormone concentration

    At subject enrollment

  • Serum free thyroxine concentration

    At subject enrollment

  • Serum free triiodothyronine concentration

    At subject enrollment

  • Serum anti-thyroglobulin autoantibody concentration

    At subject enrollment

Study Arms (2)

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

Interventions

iodineDIETARY_SUPPLEMENT

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

Users

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women at week 16 of gestation living in Debrecen and its sorroundings

You may qualify if:

  • healthy pregnant women at week 16 of gestation

You may not qualify if:

  • thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum urine

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Iodine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

HalogensElementsInorganic Chemicals

Study Officials

  • Endre V Nagy, MD, PhD, DSc

    University of Debrecen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 6, 2016

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 6, 2016

Record last verified: 2016-10