NCT06218043

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

December 27, 2023

Last Update Submit

January 11, 2024

Conditions

Nutrition, Healthy

Keywords

recommended intake of iodineiodine balance studythyroid diseaseselderly

Outcome Measures

Primary Outcomes (2)

  • Iodine intake

    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

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

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

Secondary Outcomes (5)

  • thyroid function indexes

    Within one week before the start of the experiment.

  • thyroid volumn

    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.

  • fasting blood glucose

    Within one week before the start of the experiment.

Study Arms (1)

Iodine intake intervention balance experiment

OTHER

Replace subjects' iodized salt with non-iodized salt.

Behavioral: Restrict subjects' intake of iodine-containing foods

Interventions

Restrict subjects' intake of iodine-containing foodsBEHAVIORAL

Replace subjects' iodized salt with non-iodized salt.

Iodine intake intervention balance experiment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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 Municipality, 300070, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 25591468BACKGROUND

  • 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.

    PMID: 30891786BACKGROUND

  • 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.

    PMID: 27465383BACKGROUND

  • 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.

    PMID: 5762324BACKGROUND

  • 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.

    PMID: 4208456BACKGROUND

  • Chinese Nutrition Society. Chinese Dietary Reference Intakes. Beijing, People's Medical Publishing House. 2014: 230-237. Chinese.

    BACKGROUND

  • 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.

    PMID: 32624007BACKGROUND

  • 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.

    PMID: 30526700BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Wenxing Guo

    Department of Nutrition and Food Hygiene, School of Public Health, Tianjin Medical University

    STUDY CHAIR

Central Study Contacts

Wenxing Guo, doctor

CONTACT

18822024500guowenxing@tmu.edu.cn

Zhangzhao Wang

CONTACT

13821470215graik.wang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
School of Public Health

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 23, 2024

Study Start

April 1, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(3)