Non-immune Related Hypothyroidism in Iodine Sufficient Area

NCT ID: NCT03180892

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6564 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2016-12-31

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).

Conditions

Hypothyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

The investigators did not apply any intervention for the participants.

The investigators did not apply any intervention for the participants.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jae Hoon Chung

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2017-05-149

Identifier Type: -

Identifier Source: org_study_id