Thyroid NoduleNCT01838629
the Effect of Universal Salt Iodization on Thyroid Diseases
An observational study of Thyroid Nodule, run by Weimin Xu at 1 site in China.
Trial summary
1. acquire the environmental iodine status of Hangzhou 2. acquire the iodine status of population in Hangzhou 3. acquire the prevalence of thyroid diseases in Hangzhou 4. explore the association between iodized salt and thyroid disease Read more about this study
- Who is it for?
- Ages 6 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- How many people
- 12,438 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Jun 2012
- How long will I take part?
- 1 Year
- 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 6 to 86 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study was conducted in Hangzhou, Zhejiang Province, China, which locates at east of China. This city covers eight districts and five counties. There are 8.7 millions residents in Hangzhou city; 73.25% of them living in urban areas, 26.75% in rural areas. This study was designed to be representative of the civilian from Hangzhou and collected information on demographic characteristics, health status, iodine intake and thyroid disease.
Who may be able to join
- age ≥ 6 years old;
- living for above 5 years at present residence.
Who cannot join
- resident with coronary angiography (CAG) or endoscopic retrograde cholangiopancreatography (ERCP) in 6 months;
- resident taking amiodarone drug;
- resident with abnormal kidney function or serious illness
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou Center of Disease Control and Prevention
Hangzhou, Zhejiang, 310000
About this study
- acquire the environmental iodine status of Hangzhou
- acquire the iodine status of population in Hangzhou
- acquire the prevalence of thyroid diseases in Hangzhou
- explore the association between iodized salt and thyroid disease
- Conditions
- Thyroid Nodule
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| thyroid nodule | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid nodule
An ultrasound examination of the thyroid was performed to detect thyroid nodules, using a Sonoline Versa Pro (Siemens, Munich, Germany) with a 7.5-MHz, 70-mm linear transducer (effective length, 62 mm).
Measured: 8:00am (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 12,438 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Weimin Xu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Weimin Xu, Hangzhou Center of Disease Control and Prevention
- Investigators
- Weimin Xu, Principal investigator, Hangzhou Center for Disease Control and Prevention, Hangzhou, Zhejiang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838629
- Sponsor's protocol ID
- 20090833B27
- Status last verified
- May 2013
- First submitted
- 19 Apr 2013
- Last updated
- 7 May 2013
- Results posted
- No
Publications
Xu W, Chen Z, Li N, Liu H, Huo L, Huang Y, Jin X, Deng J, Zhu S, Zhang S, Yu Y. Relationship of anthropometric measurements to thyroid nodules in a Chinese population. BMJ Open. 2015 Dec 21;5(12):e008452. doi: 10.1136/bmjopen-2015-008452.
PubMed 26692553Chen Z, Xu W, Huang Y, Jin X, Deng J, Zhu S, Liu H, Zhang S, Yu Y. Associations of noniodized salt and thyroid nodule among the Chinese population: a large cross-sectional study. Am J Clin Nutr. 2013 Sep;98(3):684-92. doi: 10.3945/ajcn.112.054353. Epub 2013 Jul 10.
PubMed 23842457
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Universal Salt Iodization on Thyroid Diseases
- ClinicalTrials.gov ID
- NCT01838629
- Acronym / sponsor ID
- 20090833B27
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,438 participants (actual)
- Lead sponsor
- Weimin XuOther government
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Apr 2013 (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.
- acquire the environmental iodine status of Hangzhou
- acquire the iodine status of population in Hangzhou
- acquire the prevalence of thyroid diseases in Hangzhou
- explore the association between iodized salt and thyroid disease
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thyroid nodule | – | – |
Who may qualify
- Ages
- 6 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was conducted in Hangzhou, Zhejiang Province, China, which locates at east of China. This city covers eight districts and five counties. There are 8.7 millions residents in Hangzhou city; 73.25% of them living in urban areas, 26.75% in rural areas. This study was designed to be representative of the civilian from Hangzhou and collected information on demographic characteristics, health status, iodine intake and thyroid disease.
Key inclusion criteria (2 listed)
- age ≥ 6 years old;
- living for above 5 years at present residence.
Key exclusion criteria (3 listed)
- resident with coronary angiography (CAG) or endoscopic retrograde cholangiopancreatography (ERCP) in 6 months;
- resident taking amiodarone drug;
- resident with abnormal kidney function or serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
thyroid nodule
Time frame: 8:00am (day 1)
An ultrasound examination of the thyroid was performed to detect thyroid nodules, using a Sonoline Versa Pro (Siemens, Munich, Germany) with a 7.5-MHz, 70-mm linear transducer (effective length, 62 mm).
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 7 May 2013.
- Derived from this study: PubMed 26692553Xu W, Chen Z, Li N, Liu H, Huo L, Huang Y, Jin X, Deng J, Zhu S, Zhang S, Yu Y. Relationship of anthropometric measurements to thyroid nodules in a Chinese population. BMJ Open. 2015 Dec 21;5(12):e008452. doi: 10.1136/bmjopen-2015-008452.
- Derived from this study: PubMed 23842457Chen Z, Xu W, Huang Y, Jin X, Deng J, Zhu S, Liu H, Zhang S, Yu Y. Associations of noniodized salt and thyroid nodule among the Chinese population: a large cross-sectional study. Am J Clin Nutr. 2013 Sep;98(3):684-92. doi: 10.3945/ajcn.112.054353. Epub 2013 Jul 10.
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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.
Weimin Xu principal investigator
Hangzhou Center for Disease Control and Prevention, Hangzhou, Zhejiang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Weimin Xu at 1 site in China.
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 2 inclusion and 3 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 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
thyroid nodule (time frame: 8:00am (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838629, which also lists 2 linked publications.
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 7 May 2013.