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

Sponsor
Tianjin Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05716191
Collaborator
Tianjin Medical University General Hospital (Other), Shandong Provincial Institute for Endemic Disease Control (Other)
1,000
34.4

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Naturally different iodine levels exposure

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Study on the Relationship Between Iodine Nutrition and Thyroid Diseases in the Elderly
Anticipated Study Start Date :
Feb 17, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Outcome Measures

Primary Outcome Measures

  1. thyroid function Indicators [2 years]

    Blood samples were collected to evaluate thyroid function.

  2. thyroid volume [2 years]

    Thyroid volume was measured by B-ultrasound.

  3. thyroid nodules [2 years]

    thyroid nodules were measured by B-ultrasound.

  4. concentration of urinary iodine [2 years]

    The midstream urine samples were collected.

  5. concentration of salivary iodine [2 years]

    The salivary samples were collected.

  6. dietary iodine intake [2 years]

    Dietary iodine was measured by idine dietary frequency questionnaire.

Secondary Outcome Measures

  1. free triiodothyronine (FT3) [2 years]

    thyroid function Indicators

  2. free thyroxine (FT4) [2 years]

    thyroid function Indicators

  3. thyroid-stimulating hormone (TSH) [2 years]

    thyroid function Indicators

  4. thyroperoxidase antibody (TPOAb) [2 years]

    thyroid function Indicators

  5. thyroglobulin antibody (TGAb) [2 years]

    thyroid function Indicators

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tianjin Medical University
  • Tianjin Medical University General Hospital
  • Shandong Provincial Institute for Endemic Disease Control

Investigators

  • Study Chair: Wenxing Guo, Public Health School, Tianjin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wenxing Guo, Lecturer, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT05716191
Other Study ID Numbers:
  • NSFC-82204041
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wenxing Guo, Lecturer, Tianjin Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023