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Clinical Trials/NCT03180892
NCT03180892CompletedNot Applicable

Non-immune Related Hypothyroidism in Iodine Sufficient Area

Samsung Medical Center0 sites6,564 target enrollmentStarted: January 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6,564
Primary Endpoint
The weighted proportion of non-immune related hypothyroidism

Study Overview

Brief 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.

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:

  1. 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.
  2. The participants who were examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC) were included.
  3. 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.
  4. This study protocol was approved by IRB of SMC (2017-05-149).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • examined for thyroid stimulating hormone, free thyroxine, thyroid peroxidase antibody (TPO Ab), and urine iodine concentration (UIC)

Exclusion Criteria

  • already have a thyroid disease(benign thyroid diseases or thyroid cancer).

Outcomes

Primary Outcomes

The weighted proportion of non-immune related hypothyroidism

Time Frame: 3 years

Hypothyroidism with TPO Ab negative

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jae Hoon Chung

M.D., Ph.D.

Samsung Medical Center

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