Non-immune Related Hypothyroidism in Iodine Sufficient Area

NCT03180892 | Completed

• 1 other identifier: 2017-05-149
• Study Type: observational
• Target: 6,564
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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. 4.This study protocol was approved by IRB of SMC (2017-05-149).

Conditions

Hypothyroidism

Keywords

Iodine; thyroid peroxidase antibody

Outcome Measures

Primary Outcomes (1)

• The weighted proportion of non-immune related hypothyroidism

  Hypothyroidism with TPO Ab negative

  3 years

Interventions

The investigators did not apply any intervention for the participants. OTHER

The investigators did not apply any intervention for the participants.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 8, 2017
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share