An Iodine Balance Study to Investigate the Recommended Iodine Intake in an Elderly Population

January 11, 2024 updated by: Wenxing Guo

An Iodine Balance Study in the Elderly

Current Chinese dietary iodine reference intake (DRIs) standards lack direct data on recommended iodine intake (RNI) in the elderly. The elderly have a high prevalence of thyroid diseases. The risk threshold of iodine intake in the elderly is unknown. Identifying the appropriate iodine intake for the elderly to maintain optimal thyroid function to reduce the burden on medical resources is a public health issue requiring high attention. The iodine balance study is an important method for exploring physiological iodine requirements. Few iodine balance studies have been conducted in the elderly. This study aimed to conduct an iodine balance study and provide information on the appropriate iodine intake level for elderly people.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators measured subjects' food and water intake throughout the day using weighing methods, and collected all urine and fecal samples. Food, drinking water, fecal and urine samples were taken to determine iodine concentrations. Each subject was required to participate in two phases of iodine balance studies. Each stage lasts 4 to 10 days. There was no intervention in the first half of the experiment, and there was an intervention of iodized salt/non-iodized salt consumption in the second half of the experiment. The appropriate level of iodine intake for the elderly was explored by fitting and analyzing the dose change relationship between iodine intake and iodine excretion.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730099
        • Recruiting
        • Gansu Provincial Center for Disease Control and Prevention
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • Shandong provincial institute for endemic disease control
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300070
        • Recruiting
        • Tianjin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

The target population of this study is elderly people over 60 years old. Adults living in the same household can also participate.

Inclusion Criteria:

  1. aged 18 and above;
  2. at least 5 years of local residence.

Exclusion Criteria:

  1. family genetic diseases；
  2. special dietary habits；
  3. taking iodine-containing drugs or supplements；
  4. metabolic diseases;
  5. thyroid diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Iodine intake intervention balance experiment
Replace subjects' iodized salt with non-iodized salt.
Behavioral: Restrict subjects' intake of iodine-containing foods
Replace subjects' iodized salt with non-iodized salt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iodine intake
Time Frame: Each phase of the iodine balance study lasts 4 to 10 days.
Daily iodine intake includes dietary iodine intake and drinking water iodine intake.
Each phase of the iodine balance study lasts 4 to 10 days.
Iodine excretion
Time Frame: Each phase of the iodine balance study lasts 4 to 10 days.
Daily iodine excretion includes urinary iodine excretion and fecal iodine excretion.
Each phase of the iodine balance study lasts 4 to 10 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thyroid function indexes
Time Frame: Within one week before the start of the experiment.
FT3、FT4、TSH、TPOAb、TGAb. Each subject was asked to collect venous blood twice (before the experiment and within one week after the intervention) to measure indicators of thyroid work.
Within one week before the start of the experiment.
thyroid volumn
Time Frame: Within one week before the start of the experiment.
Thyroid volume was measured using thyroid B-ultrasound.
Within one week before the start of the experiment.
salivary iodine
Time Frame: 4 to 10 days
Every time the subject urinates, 2ml of saliva is collected.
4 to 10 days
blood pressure
Time Frame: Within one week before the start of the experiment.
Subjects had their blood pressure measured before and after the study.
Within one week before the start of the experiment.
fasting blood glucose
Time Frame: Within one week before the start of the experiment.
Subjects had their fasting blood glucose measured before and after the study.
Within one week before the start of the experiment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenxing Guo

Collaborators

Tianjin Medical University General Hospital
Gansu Provincial Centre for Disease Control and Prevention

Investigators

  • Study Chair: Wenxing Guo, Department of Nutrition and Food Hygiene, School of Public Health, Tianjin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Estimated)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 82204041-NSFC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data of the study are available from the project leader upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nutrition, Healthy

Clinical Trials on Restrict subjects' intake of iodine-containing foods

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe