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

An Iodine Balance Study in the Elderly

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06218043
Enrollment
30
Registered
2024-01-23
Start date
2023-04-01
Completion date
2025-12-31
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

Keywords

recommended intake of iodine, iodine balance study, thyroid diseases, elderly

Brief summary

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.

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.

Interventions

BEHAVIORALRestrict subjects' intake of iodine-containing foods

Replace subjects' iodized salt with non-iodized salt.

Sponsors

Tianjin Medical University General Hospital
CollaboratorOTHER
Gansu Provincial Centre for Disease Control and Prevention
CollaboratorUNKNOWN
Wenxing Guo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

When the first phase of the iodine balance study without intervention is completed. After an interval of 4 days, subjects who eat iodized salt will be included, the iodized salt will be replaced with non-iodized salt, and the second phase of the iodine balance experiment will begin.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Iodine intakeEach phase of the iodine balance study lasts 4 to 10 days.Daily iodine intake includes dietary iodine intake and drinking water iodine intake.
Iodine excretionEach phase of the iodine balance study lasts 4 to 10 days.Daily iodine excretion includes urinary iodine excretion and fecal iodine excretion.

Secondary

MeasureTime frameDescription
salivary iodine4 to 10 daysEvery time the subject urinates, 2ml of saliva is collected.
thyroid function indexesWithin 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.
fasting blood glucoseWithin one week before the start of the experiment.Subjects had their fasting blood glucose measured before and after the study.
blood pressureWithin one week before the start of the experiment.Subjects had their blood pressure measured before and after the study.
thyroid volumnWithin one week before the start of the experiment.Thyroid volume was measured using thyroid B-ultrasound.

Countries

China

Contacts

Primary ContactWenxing Guo, doctor
guowenxing@tmu.edu.cn18822024500
Backup ContactZhangzhao Wang
graik.wang@163.com13821470215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026