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

NCT ID: NCT06218043

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Iodine intake intervention balance experiment

Replace subjects' iodized salt with non-iodized salt.

Group Type OTHER

Restrict subjects' intake of iodine-containing foods

Intervention Type BEHAVIORAL

Replace subjects' iodized salt with non-iodized salt.

Interventions

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Restrict subjects' intake of iodine-containing foods

Replace subjects' iodized salt with non-iodized salt.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenxing Guo

OTHER

Sponsor Role lead

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Gansu Provincial Centre for Disease Control and Prevention

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Wenxing Guo

School of Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenxing Guo

Role: STUDY_CHAIR

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

Locations

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Gansu provincial center for disease control and prevention

Lanzhou, Gansu, China

Site Status RECRUITING

Shandong provincial institute for endemic disease control

Jinan, Shandong, China

Site Status RECRUITING

Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenxing Guo, doctor

Role: CONTACT

18822024500

Zhangzhao Wang

Role: CONTACT

13821470215

Facility Contacts

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Yanling Wang

Role: primary

18189527633

Xiaoming Wang

Role: primary

0531-88569613

Wenxing Guo, Doctor

Role: primary

18822024500

References

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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.

Reference Type BACKGROUND
PMID: 25591468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30891786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27465383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5762324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4208456 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 32624007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30526700 (View on PubMed)

Other Identifiers

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82204041-NSFC

Identifier Type: -

Identifier Source: org_study_id

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