Dietary Iodine DeficiencyNCT02927119
Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy
An observational study of Dietary Iodine Deficiency and Thyroid; Functional Disturbance, run by University of Debrecen.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dietary Iodine Deficiency, Thyroid; Functional Disturbance
- What is being tested?
- iodine
- How many people
- 189 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women at week 16 of gestation living in Debrecen and its sorroundings
Who may be able to join
- healthy pregnant women at week 16 of gestation
Who cannot join
- thyroid disease
About this study
Official title: Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population
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.
Read the 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.
- Being tested
- iodine
- Keywords
- thyroglobulin, iodine, pregnancy
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodineDietary supplement
≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration
Measured: At subject enrollment
Serum thyroglobulin concentration
Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay
Measured: At subject enrollment
Secondary outcomes (4)
Serum thyroid stimulating hormone concentration
Measurement of serum thyroid stimulating hormone concentration by electrochemiluminescence immunoassay
Measured: At subject enrollment
Serum free thyroxine concentration
Measurement of serum free thyroxine concentration by electrochemiluminescence immunoassay
Measured: At subject enrollment
Serum free triiodothyronine concentration
Measurement of serum free triiodothyronine concentration by electrochemiluminescence immunoassay
Measured: At subject enrollment
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)
Measured: At subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Endre V Nagy, University of Debrecen
- Investigators
- Endre V Nagy, MD, PhD, DSc, Principal investigator, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927119
- Sponsor's protocol ID
- GRAV-TG
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population
- ClinicalTrials.gov ID
- NCT02927119
- Acronym / sponsor ID
- GRAV-TG
- Keywords
- thyroglobulin, iodine, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-users | – | –Pregnant women who had not taken dietary iodine supplement before and during pregnancy. |
| Users | – | Dietary Supplement: iodinePregnant women who had taken dietary iodine supplement before and/or during pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women at week 16 of gestation living in Debrecen and its sorroundings
Key inclusion criteria (1 listed)
- healthy pregnant women at week 16 of gestation
Key exclusion criteria (1 listed)
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iodine≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment | Dietary supplement | Users |
Primary outcome
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
4 secondary outcomes
Serum thyroid stimulating hormone concentration
Time frame: At subject enrollment
Serum free thyroxine concentration
Time frame: At subject enrollment
Serum free triiodothyronine concentration
Time frame: At subject enrollment
Serum anti-thyroglobulin autoantibody concentration
Time frame: At subject enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Endre V Nagy, MD, PhD, DSc principal investigator
University of Debrecen
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Iodine Deficiency and Thyroid; Functional Disturbance, run by University of Debrecen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (time frame: At subject enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.