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Nutrition, HealthyNCT05716191

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

An observational study of Nutrition, Healthy and Elderly, run by Tianjin Medical University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Nutrition, Healthy, Elderly
What is being tested?
Naturally different iodine levels exposure
How many people
1,000 participants
Where
3 sitesChina
Study dates
17 Feb 2023to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Elderly people with different levels of iodine exposure.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Wenxing Guo, Doctor contact

(86)18822024500

guowenxing@tmu.edu.cn

Zhangzhao Wang, Doctor contact

(86)13821470215

graik.wang@163.com

China3 sites, 2 recruiting

  • Shandong provincial institute for endemic disease control

    Jinan, Shandong, 250014

    Xiaoming Wang

    Recruiting

  • Gansu provincial center for disease control and prevention

    Lanzhou, Gansu, 730099

    Yanling Wang

    Recruiting

  • Tianjin Medical University

    Tianjin, Tianjin Municipality, 300070

    Active, not recruiting

Other trials in China

About this study

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.
Read the detailed 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.

Being tested
Naturally different iodine levels exposure
Keywords
iodine, thyroid diseases, adults
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naturally different iodine levels exposureOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. thyroid function Indicators

    Blood samples were collected to evaluate thyroid function.

    Measured: 2 years

  2. thyroid volume

    Thyroid volume was measured by B-ultrasound.

    Measured: 2 years

  3. thyroid nodules

    thyroid nodules were measured by B-ultrasound.

    Measured: 2 years

  4. concentration of urinary iodine

    The midstream urine samples were collected.

    Measured: 2 years

  5. concentration of salivary iodine

    The salivary samples were collected.

    Measured: 2 years

  6. dietary iodine intake

    Dietary iodine was measured by idine dietary frequency questionnaire.

    Measured: 2 years

Secondary outcomes (5)

  1. free triiodothyronine (FT3)

    thyroid function Indicators

    Measured: 2 years

  2. free thyroxine (FT4)

    thyroid function Indicators

    Measured: 2 years

  3. thyroid-stimulating hormone (TSH)

    thyroid function Indicators

    Measured: 2 years

  4. thyroperoxidase antibody (TPOAb)

    thyroid function Indicators

    Measured: 2 years

  5. thyroglobulin antibody (TGAb)

    thyroid function Indicators

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start17 Feb 2023
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716191
Sponsor's protocol ID
NSFC-82204041
Status last verified
Aug 2023
First submitted
21 Dec 2022
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data of the study are available from the project leader upon reasonable request.

Publications

  • 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.

    PubMed 25591468

  • 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.

    PubMed 24342882

  • 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.

    PubMed 32075540

  • 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.

    PubMed 27455319

  • 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.

    PubMed 20172467

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

    PubMed 30606015

  • 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.

    PubMed 30351201

  • 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.

    PubMed 30032140

  • 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.

    PubMed 34684487

  • 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.

    PubMed 39441230

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition, Healthy and Elderly, run by Tianjin Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenxing Guo, Doctor ((86)18822024500, guowenxing@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

thyroid function Indicators (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716191, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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