NCT05716191

Brief 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. 1.to clarify the differences in the prevalence of thyroid diseases in the elderly with different iodine nutrition backgrounds.
  2. 2.to analyze the effects of mild iodine deficiency and iodine excess on the thyroid health of the elderly.
  3. 3.to explore the hazard threshold of iodine intake for old people.
  4. 4.to compare the differences in thyroid disease and iodine nutritional status between young and middle-aged people and old people.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

December 21, 2022

Last Update Submit

August 12, 2023

Conditions

Keywords

iodinethyroid diseasesadults

Outcome Measures

Primary Outcomes (6)

  • thyroid function Indicators

    Blood samples were collected to evaluate thyroid function.

    2 years

  • thyroid volume

    Thyroid volume was measured by B-ultrasound.

    2 years

  • thyroid nodules

    thyroid nodules were measured by B-ultrasound.

    2 years

  • concentration of urinary iodine

    The midstream urine samples were collected.

    2 years

  • concentration of salivary iodine

    The salivary samples were collected.

    2 years

  • dietary iodine intake

    Dietary iodine was measured by idine dietary frequency questionnaire.

    2 years

Secondary Outcomes (5)

  • free triiodothyronine (FT3)

    2 years

  • free thyroxine (FT4)

    2 years

  • thyroid-stimulating hormone (TSH)

    2 years

  • thyroperoxidase antibody (TPOAb)

    2 years

  • thyroglobulin antibody (TGAb)

    2 years

Interventions

A cross-sectional survey of thyroid disease in elderly people in areas with different iodine nutrition backgrounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly people with different levels of iodine exposure.

You may qualify if:

  • \. adults with at least 5 years of local residence;

You may not qualify if:

  • adults with family genetic diseases
  • adults with special dietary habits
  • adults taking iodine-containing drugs or supplements
  • adults with protein or nutritional deficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gansu provincial center for disease control and prevention

Lanzhou, Gansu, 730099, China

RECRUITING

Shandong provincial institute for endemic disease control

Jinan, Shandong, 250014, China

RECRUITING

Tianjin Medical University

Tianjin, Tianjin Municipality, 300070, China

ACTIVE NOT RECRUITING

Related Publications (10)

  • 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.

    PMID: 25591468BACKGROUND
  • 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.

    PMID: 24342882BACKGROUND
  • 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.

    PMID: 32075540BACKGROUND
  • 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.

    PMID: 27455319BACKGROUND
  • 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.

    PMID: 20172467BACKGROUND
  • Limanova Z. [Thyroid disease in the elderly]. Vnitr Lek. 2018 Winter;64(11):993-1002. Czech.

    PMID: 30606015BACKGROUND
  • 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.

    PMID: 30351201BACKGROUND
  • 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.

    PMID: 30032140BACKGROUND
  • 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.

    PMID: 34684487BACKGROUND
  • Jin Q, Wang Z, Li J, Zhang H, Liu M, Wang C, Guo W, Zhang W. Iodine Excess Is Associated with Thyroid Dysfunction Among the Elderly. Biol Trace Elem Res. 2025 Jul;203(7):3470-3478. doi: 10.1007/s12011-024-04420-0. Epub 2024 Oct 23.

Biospecimen

Retention: SAMPLES WITHOUT DNA

1.Urinary iodine concentration was measured by collecting spot urine and 24-h urine samples. 2.Blood samples were collected to evaluate thyroid function. 3.Thyroid B-ultrasonography was conducted to measure the thyroid volume and thyroid nodule. 4.Saliva samples were collected to measure saliva iodine. 5.The iodine dietary frequency questionnaire was used to assess the long-term iodine intake level of the subjects.

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Wenxing Guo, Doctor

    Public Health School, Tianjin Medical University

    STUDY CHAIR

Central Study Contacts

Wenxing Guo, Doctor

CONTACT

Zhangzhao Wang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 21, 2022

First Posted

February 8, 2023

Study Start

February 17, 2023

Primary Completion

June 1, 2025

Study Completion

December 30, 2025

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations