Non-immune Related Hypothyroidism in Iodine Sufficient Area

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03180892

Collaborator

(none)

6,564

Enrollment

Actual Duration (Months)

Study Details

Study Description

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:

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).

Condition or Disease	Intervention/Treatment	Phase
Hypothyroidism	Other: The investigators did not apply any intervention for the participants.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

6564 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Non-immune Related Hypothyroidism in Iodine Sufficient Area

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Outcome Measures

Primary Outcome Measures

The weighted proportion of non-immune related hypothyroidism [3 years]
Hypothyroidism with TPO Ab negative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jae Hoon Chung, M.D., Ph.D., Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03180892

Other Study ID Numbers:

2017-05-149

First Posted:

Jun 8, 2017

Last Update Posted:

Jun 9, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jae Hoon Chung, M.D., Ph.D., Samsung Medical Center

Iodine

thyroid peroxidase antibody

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Jun 9, 2017