Non-immune Related Hypothyroidism in Iodine Sufficient Area

Hypothyroidism Clinical Trial

Official title:

Non-immune Related Hypothyroidism in Iodine Sufficient Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180892
• Other study ID #: 2017-05-149
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 7, 2017
• Start date: January 1, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6564
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Other:
• The investigators did not apply any intervention for the participants.
The investigators did not apply any intervention for the participants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The weighted proportion of non-immune related hypothyroidism	Hypothyroidism with TPO Ab negative	3 years