Study on the Relationship Between Iodine Nutrition and Thyroid Diseases in the Elderly

Elderly Clinical Trial

Official title:

Study on the Relationship Between Iodine Nutrition and Thyroid Diseases in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716191
• Other study ID #: NSFC-82204041
• Status: Recruiting
• Start date: February 17, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: August 2023
• Source: Tianjin Medical University
• Contact: Wenxing Guo, Doctor
• Phone: (86)18822024500
• Email: guowenxing[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aging trend of China's population is intensifying. More than 50% of the elderly in China suffer from thyroid disease. Thyroid dysfunction in the elderly increases the risk of cardiovascular and metabolic diseases. Even if thyroid-stimulating hormone (TSH) is within the normal range, brain atrophy and infarction-like vascular damage in elderly males will be aggravated with the increased TSH level. Iodine is an essential component of thyroid hormones. Iodine deficiency or excess may lead to a series of thyroid diseases. The risk threshold of iodine intake in the elderly is unknown. The goal of this observational study is to clarify the relationship between thyroid diseases and iodine intake in the elderly. The aims are:

1. to clarify the differences in the prevalence of thyroid diseases in the elderly with different iodine nutrition backgrounds.

2. to analyze the effects of mild iodine deficiency and iodine excess on the thyroid health of the elderly.

3. to explore the hazard threshold of iodine intake for old people.

4. to compare the differences in thyroid disease and iodine nutritional status between young and middle-aged people and old people.

Description:

Part 1：A cross-sectional survey of thyroid diseases in adults in different iodine nutrition background areas.

Investigators will separately include adults ( middle-aged people and old people) in iodine-deficient, iodine-appropriate, and iodine-excessive areas. Venous blood will be collected to measure thyroid function and serum iodine. Thyroid volume and nodular disease were determined by B-ultrasonography. Drinking water, saliva and 24-h and spot urinary samples will be collected to precisely evaluate the daily iodine intake. Multiple indicators were used to accurately evaluate the iodine intake level of the subjects, and understand the differences in the prevalence of thyroid diseases in the elderly under different iodine nutrition backgrounds. Besides, the differences in thyroid disease and iodine nutritional status between young and middle-aged people and old people will be compared.

Part 2：A survey on the iodine nutrition status in the elderly with/without thyroid disease in iodine-appropriate areas.

Investigators will collect basic information (height, weight, age, other medical histories, etc.) and thyroid disease history information. Thyroid B-ultrasound and thyroid function tests were used to understand the current thyroid status of the elderly. The iodine dietary frequency questionnaire was used to assess the long-term iodine intake level of the survey subjects, and spot urinary iodine, 24-h urinary iodine and salivary iodine were used to assess the short-term iodine intake level of the survey subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. adults with at least 5 years of local residence;

Exclusion Criteria:

1. adults with family genetic diseases

2. adults with special dietary habits

3. adults taking iodine-containing drugs or supplements

4. adults with protein or nutritional deficiencies

Related Conditions & MeSH terms

• Elderly
• Thyroid Diseases

Intervention

Other:
• Naturally different iodine levels exposure
A cross-sectional survey of thyroid disease in elderly people in areas with different iodine nutrition backgrounds

Locations

Country	Name	City	State
China	Shandong provincial institute for endemic disease control	Jinan	Shandong
China	Gansu provincial center for disease control and prevention	Lanzhou	Gansu
China	Tianjin Medical University	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Tianjin Medical University	Shandong Provincial Institute for Endemic Disease Control, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Barbesino G. Thyroid Function Changes in the Elderly and Their Relationship to Cardiovascular Health: A Mini-Review. Gerontology. 2019;65(1):1-8. doi: 10.1159/000490911. Epub 2018 Jul 20. — View Citation

Iacone R, Iaccarino Idelson P, Russo O, Donfrancesco C, Krogh V, Sieri S, Macchia PE, Formisano P, Lo Noce C, Palmieri L, Galeone D, Rendina D, Galletti F, Di Lenarda A, Giampaoli S, Strazzullo P, On Behalf Of The Minisal-Gircsi Study Group. Iodine Intake from Food and Iodized Salt as Related to Dietary Salt Consumption in the Italian Adult General Population. Nutrients. 2021 Sep 30;13(10):3486. doi: 10.3390/nu13103486. — View Citation

Laurberg P, Cerqueira C, Ovesen L, Rasmussen LB, Perrild H, Andersen S, Pedersen IB, Carle A. Iodine intake as a determinant of thyroid disorders in populations. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):13-27. doi: 10.1016/j.beem.2009.08.013. — View Citation

Leung AM, Braverman LE. Consequences of excess iodine. Nat Rev Endocrinol. 2014 Mar;10(3):136-42. doi: 10.1038/nrendo.2013.251. Epub 2013 Dec 17. — View Citation

Li Y, Teng D, Ba J, Chen B, Du J, He L, Lai X, Teng X, Shi X, Li Y, Chi H, Liao E, Liu C, Liu L, Qin G, Qin Y, Quan H, Shi B, Sun H, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Shan Z, Teng W. Efficacy and Safety of Long-Term Universal Salt Iodization on Thyroid Disorders: Epidemiological Evidence from 31 Provinces of Mainland China. Thyroid. 2020 Apr;30(4):568-579. doi: 10.1089/thy.2019.0067. Epub 2020 Mar 24. — View Citation

Limanova Z. Thyroid disease in the elderly. Vnitr Lek. 2018 Winter;64(11):993-1002. — View Citation

Miller JC, MacDonell SO, Gray AR, Reid MR, Barr DJ, Thomson CD, Houghton LA. Iodine Status of New Zealand Elderly Residents in Long-Term Residential Care. Nutrients. 2016 Jul 23;8(8):445. doi: 10.3390/nu8080445. — View Citation

Zhai X, Zhang L, Chen L, Lian X, Liu C, Shi B, Shi L, Tong N, Wang S, Weng J, Zhao J, Teng X, Yu X, Lai Y, Wang W, Li C, Mao J, Li Y, Fan C, Li L, Shan Z, Teng W. An Age-Specific Serum Thyrotropin Reference Range for the Diagnosis of Thyroid Diseases in Older Adults: A Cross-Sectional Survey in China. Thyroid. 2018 Dec;28(12):1571-1579. doi: 10.1089/thy.2017.0715. Epub 2018 Nov 27. — View Citation

Zimmermann MB, Boelaert K. Iodine deficiency and thyroid disorders. Lancet Diabetes Endocrinol. 2015 Apr;3(4):286-95. doi: 10.1016/S2213-8587(14)70225-6. Epub 2015 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thyroid function Indicators	Blood samples were collected to evaluate thyroid function.	2 years
Primary	thyroid volume	Thyroid volume was measured by B-ultrasound.	2 years
Primary	thyroid nodules	thyroid nodules were measured by B-ultrasound.	2 years
Primary	concentration of urinary iodine	The midstream urine samples were collected.	2 years
Primary	concentration of salivary iodine	The salivary samples were collected.	2 years
Primary	dietary iodine intake	Dietary iodine was measured by idine dietary frequency questionnaire.	2 years
Secondary	free triiodothyronine (FT3)	thyroid function Indicators	2 years
Secondary	free thyroxine (FT4)	thyroid function Indicators	2 years
Secondary	thyroid-stimulating hormone (TSH)	thyroid function Indicators	2 years
Secondary	thyroperoxidase antibody (TPOAb)	thyroid function Indicators	2 years
Secondary	thyroglobulin antibody (TGAb)	thyroid function Indicators	2 years