CClinicalTrials.gg
RecruitingNCT06218043Updated Jan 23, 2024

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

An interventional study of Restrict subjects' intake of iodine-containing foods in Nutrition, Healthy, sponsored by Wenxing Guo. Recruiting at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Wenxing Guo · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Apr 2023, registered Dec 2023).
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nutrition, Healthy

Keywords

  • recommended intake of iodine
  • iodine balance study
  • thyroid diseases
  • elderly
03

In context

Lead sponsor

This is the only study on the registry with Wenxing Guo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Inclusion criteria

Inclusion Criteria:

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

Exclusion criteria

Exclusion Criteria:

  1. family genetic diseases;
  2. special dietary habits;
  3. taking iodine-containing drugs or supplements;
  4. metabolic diseases;
  5. thyroid diseases.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Iodine intake intervention balance experiment

    Replace subjects' iodized salt with non-iodized salt.

    Behavioral: Restrict subjects' intake of iodine-containing foods

Interventions

  • BehavioralRestrict subjects' intake of iodine-containing foods

    Replace subjects' iodized salt with non-iodized salt.

06

What researchers measure

Primary outcomes

  1. Iodine intake

    Daily iodine intake includes dietary iodine intake and drinking water iodine intake.

    Time frame: Each phase of the iodine balance study lasts 4 to 10 days.

  2. Iodine excretion

    Daily iodine excretion includes urinary iodine excretion and fecal iodine excretion.

    Time frame: Each phase of the iodine balance study lasts 4 to 10 days.

Secondary outcomes

  1. thyroid function indexes

    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.

    Time frame: Within one week before the start of the experiment.

  2. thyroid volumn

    Thyroid volume was measured using thyroid B-ultrasound.

    Time frame: Within one week before the start of the experiment.

  3. salivary iodine

    Every time the subject urinates, 2ml of saliva is collected.

    Time frame: 4 to 10 days

  4. blood pressure

    Subjects had their blood pressure measured before and after the study.

    Time frame: Within one week before the start of the experiment.

  5. fasting blood glucose

    Subjects had their fasting blood glucose measured before and after the study.

    Time frame: Within one week before the start of the experiment.

07

Study locations

3 of 3 sites recruiting
  • Gansu provincial center for disease control and prevention
    Lanzhou, Gansu 730099, China
    Recruiting
  • Shandong provincial institute for endemic disease control
    Jinan, Shandong 250014, China
    Recruiting
  • Tianjin Medical University
    Tianjin, Tianjin 300070, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25591468 ↗
  • Farebrother J, Zimmermann MB, Andersson M. Excess iodine intake: sources, assessment, and effects on thyroid function. Ann N Y Acad Sci. 2019 Jun;1446(1):44-65. doi: 10.1111/nyas.14041. Epub 2019 Mar 20. PubMed 30891786 ↗
  • Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27. PubMed 27465383 ↗
  • Malvaux P, Beckers C, De Visscher M. Iodine balance studies in nongoitrous children and in adolescents on low iodine intake. J Clin Endocrinol Metab. 1969 Jan;29(1):79-84. doi: 10.1210/jcem-29-1-79. No abstract available. PubMed 5762324 ↗
  • Ingenbleek Y, Malvaux P. Iodine balance studies in protein-calorie malnutrition. Arch Dis Child. 1974 Apr;49(4):305-9. doi: 10.1136/adc.49.4.305. PubMed 4208456 ↗
  • Chinese Nutrition Society. Chinese Dietary Reference Intakes. Beijing, People's Medical Publishing House. 2014: 230-237. Chinese.
  • Yang L, Wang J, Yang J, Zhang H, Liu X, Mao D, Lu J, Gu Y, Li X, Wang H, Xu J, Tan H, Zhang H, Yu W, Tao X, Fan Y, Cai Q, Liu X, Yang X. An iodine balance study to explore the recommended nutrient intake of iodine in Chinese young adults. Br J Nutr. 2020 Dec 14;124(11):1156-1165. doi: 10.1017/S0007114520002196. Epub 2020 Jun 22. PubMed 32624007 ↗
  • Tan L, Tian X, Wang W, Guo X, Sang Z, Li X, Zhang P, Sun Y, Tang C, Xu Z, Shen J, Zhang W. Exploration of the appropriate recommended nutrient intake of iodine in healthy Chinese women: an iodine balance experiment. Br J Nutr. 2019 Mar 14;121(5):519-528. doi: 10.1017/S0007114518003653. Epub 2018 Dec 11. PubMed 30526700 ↗

Individual participant data

Plan to share: No — The data of the study are available from the project leader upon reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06218043
Lead sponsor
Wenxing Guo
Collaborators
Tianjin Medical University General Hospital, Gansu Provincial Centre for Disease Control and Prevention
Responsible party
Wenxing Guo (School of Public Health, Tianjin Medical University) — Sponsor-investigator
First posted
Jan 23, 2024
Start date
Apr 1, 2023
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 23, 2024

Study contacts

Wenxing Guo, doctor
Contact
guowenxing@tmu.edu.cn
18822024500
Zhangzhao Wang
Contact
graik.wang@163.com
13821470215
Wenxing Guo
study chair · Department of Nutrition and Food Hygiene, School of Public Health, Tianjin Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion