Study on the Relationship Between Iodine Nutrition and Th... | NCT05716191

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

NCT05716191

Sponsor

Tianjin Medical University

Status

Unknown status

Last Update Posted

Aug 16, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Nutrition, Healthy
Elderly

Interventions

Naturally different iodine levels exposure

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2023Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Dec 21, 2022

First Submission Date that Met QC Criteria

Feb 3, 2023

First Posted Date

Feb 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2023

Last Update Posted Date

Aug 16, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wenxing Guo, Lecturer, Tianjin Medical UniversityPrincipal Investigator

Lead Sponsor

Tianjin Medical UniversityOTHER

Collaborators

Name	Class
Tianjin Medical University General Hospital	OTHER
Shandong Provincial Institute for Endemic Disease Control	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naturally different iodine levels exposure	Other	A cross-sectional survey of thyroid disease in elderly people in areas with different iodine nutrition backgrounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
free triiodothyronine (FT3)	thyroid function Indicators	2 years
free thyroxine (FT4)	thyroid function Indicators	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Elderly people with different levels of iodine exposure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenxing Guo, Doctor	Contact	(86)18822024500		guowenxing@tmu.edu.cn
Zhangzhao Wang, Doctor	Contact	(86)13821470215		graik.wang@163.com

Overall Officials

Name	Affiliation	Role
Wenxing Guo, Doctor	Public Health School, Tianjin Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gansu provincial center for disease control and prevention	Recruiting	Lanzhou	Gansu	730099	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25591468	Background	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.
24342882	Background	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.