HypothyroidismNCT03180892
Non-immune Related Hypothyroidism in Iodine Sufficient Area
An observational study of Hypothyroidism, run by Samsung Medical Center.
Trial summary
Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary hypothyroidism in iodine sufficient area and has relationship with excess iodine induced hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess iodine have been rarely evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- The investigators did not apply any intervention for the participants.
- How many people
- 6,564 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2016
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The investigators used a dataset from the KNHANES VI (2013 to 2015), a nationwide, cross-sectional survey of the Korean population for surveillance of health and nutritional status. The survey used stratified, multistage clustered probability sampling to select a representative sample of the civilian non-institutionalized Korean population. Research subjects were selected through two-stage stratified cluster sampling using population and housing census data. The investigators included the subjects who were examined for TSH, FT4, TPO Ab, and UIC. Subjects previously diagnosed with benign thyroid diseases or thyroid cancer were excluded.
Who may be able to join
- examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC)
Who cannot join
- already have a thyroid disease(benign thyroid diseases or thyroid cancer).
About this study
Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary hypothyroidism in iodine sufficient area and has relationship with excess iodine induced hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess iodine have been rarely evaluated.
Objective: Therefore, the investigators planned to calculate proportion of non-immune related hypothyroidism and relationship with iodine intake using nationwide data from Korea National Health and Nutrition Examination Survey (KNHANES) 2013-2015.
Read more
Design:
- Korea National Health and Nutrition Examination Survey VI (2013 to 2015) - The national data - which is the government designated statistics (Approval No. 117002 ) of South Korea based on the Article 17 of the National Health Promotion Act - were used. The survey was approved by the Institutional Review Board of the Korea Centers for Disease Control and Prevention, and provides only non-identified measures for academic research purposes.
- The participants who were examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were included.
- The proportion of immune related and non-immune related hypothyroidism was evaluated. Demographic variables and severity of hypothyroidism were compared between the two groups. To analyze iodine effect on hypothyroidism in TPO Ab positive or negative population, prevalence of hypothyroidism were assessed in each TPO Ab negative and positive population according to UIC subgroups.
- This study protocol was approved by IRB of SMC (2017-05-149).
- Conditions
- Hypothyroidism
- Being tested
- The investigators did not apply any intervention for the participants.
- Keywords
- Iodine, thyroid peroxidase antibody
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The investigators did not apply any intervention for the participants.Other
The investigators did not apply any intervention for the participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
The weighted proportion of non-immune related hypothyroidism
Hypothyroidism with TPO Ab negative
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 6,564 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hoon Chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180892
- Sponsor's protocol ID
- 2017-05-149
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This data is national data of Korea. It is already possible to use the data freely only for the purpose of academic research and the like.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-immune Related Hypothyroidism in Iodine Sufficient Area
- ClinicalTrials.gov ID
- NCT03180892
- Acronym / sponsor ID
- 2017-05-149
- Conditions
- Hypothyroidism
- Keywords
- Iodine, thyroid peroxidase antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,564 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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.
Background: Autoimmune hypothyroidism has been regarded as the most common cause of primary hypothyroidism in iodine sufficient area and has relationship with excess iodine induced hypothyroidism. However, non-immune related hypothyroidism and its relationship with excess iodine have been rarely evaluated.
Objective: Therefore, the investigators planned to calculate proportion of non-immune related hypothyroidism and relationship with iodine intake using nationwide data from Korea National Health and Nutrition Examination Survey (KNHANES) 2013-2015.
Design:
- Korea National Health and Nutrition Examination Survey VI (2013 to 2015) - The national data - which is the government designated statistics (Approval No. 117002 ) of South Korea based on the Article 17 of the National Health Promotion Act - were used. The survey was approved by the Institutional Review Board of the Korea Centers for Disease Control and Prevention, and provides only non-identified measures for academic research purposes.
- The participants who were examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were included.
- The proportion of immune related and non-immune related hypothyroidism was evaluated. Demographic variables and severity of hypothyroidism were compared between the two groups. To analyze iodine effect on hypothyroidism in TPO Ab positive or negative population, prevalence of hypothyroidism were assessed in each TPO Ab negative and positive population according to UIC subgroups.
- This study protocol was approved by IRB of SMC (2017-05-149).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigators used a dataset from the KNHANES VI (2013 to 2015), a nationwide, cross-sectional survey of the Korean population for surveillance of health and nutritional status. The survey used stratified, multistage clustered probability sampling to select a representative sample of the civilian non-institutionalized Korean population. Research subjects were selected through two-stage stratified cluster sampling using population and housing census data. The investigators included the subjects who were examined for TSH, FT4, TPO Ab, and UIC. Subjects previously diagnosed with benign thyroid diseases or thyroid cancer were excluded.
Key inclusion criteria (1 listed)
- examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC)
Key exclusion criteria (1 listed)
- already have a thyroid disease(benign thyroid diseases or thyroid cancer).
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 |
|---|---|---|
| The investigators did not apply any intervention for the participants.The investigators did not apply any intervention for the participants. | Other | – |
Primary outcome
The weighted proportion of non-immune related hypothyroidism
Time frame: 3 years
Hypothyroidism with TPO Ab negative
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 9 Jun 2017.
- Individual participant dataSharing planned: Yes. This data is national data of Korea. It is already possible to use the data freely only for the purpose of academic research and the like.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Samsung Medical Center.
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 9 Jun 2017. 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?
The weighted proportion of non-immune related hypothyroidism (time frame: 3 years). 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 9 Jun 2017.