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Clinical Trials/NCT06218043
NCT06218043RecruitingNot Applicable

An Iodine Balance Study in the Elderly

Wenxing Guo3 sites in 1 country30 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
3
Primary Endpoint
Iodine excretion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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:
  • aged 18 and above;
  • at least 5 years of local residence.

Exclusion Criteria

  • family genetic diseases;
  • special dietary habits;
  • taking iodine-containing drugs or supplements;
  • metabolic diseases;
  • thyroid diseases.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • thyroid function indexes(Within one week before the start of the experiment.)
  • salivary iodine(4 to 10 days)
  • blood pressure(Within one week before the start of the experiment.)
  • thyroid volumn(Within one week before the start of the experiment.)
  • fasting blood glucose(Within one week before the start of the experiment.)

Investigators

Sponsor
Wenxing Guo
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Wenxing Guo

School of Public Health

Tianjin Medical University

Study Sites (3)

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