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临床试验/NCT05716191
NCT05716191招募中不适用

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

Tianjin Medical University3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
3
主要终点
thyroid nodules

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults with at least 5 years of local residence;

排除标准

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

结局指标

主要结局

thyroid nodules

时间窗: 2 years

thyroid nodules were measured by B-ultrasound.

thyroid function Indicators

时间窗: 2 years

Blood samples were collected to evaluate thyroid function.

concentration of urinary iodine

时间窗: 2 years

The midstream urine samples were collected.

concentration of salivary iodine

时间窗: 2 years

The salivary samples were collected.

thyroid volume

时间窗: 2 years

Thyroid volume was measured by B-ultrasound.

dietary iodine intake

时间窗: 2 years

Dietary iodine was measured by idine dietary frequency questionnaire.

次要结局

  • free thyroxine (FT4)(2 years)
  • thyroglobulin antibody (TGAb)(2 years)
  • free triiodothyronine (FT3)(2 years)
  • thyroperoxidase antibody (TPOAb)(2 years)
  • thyroid-stimulating hormone (TSH)(2 years)

研究者

发起方
Tianjin Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenxing Guo

Lecturer

Tianjin Medical University

研究点 (3)

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