Nutrition, HealthyNCT06218043
An Iodine Balance Study to Investigate the Recommended Iodine Intake in an Elderly Population
A study testing Restrict subjects' intake of iodine-containing foods in people with Nutrition, Healthy, run by Wenxing Guo at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Restrict subjects' intake of iodine-containing foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 and above;
- at least 5 years of local residence.
Who cannot join
- family genetic diseases；
- special dietary habits；
- taking iodine-containing drugs or supplements；
- metabolic diseases;
- thyroid diseases.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Shandong provincial institute for endemic disease control
Jinan, Shandong, 250014
Xiaoming Wang, 0531-88569613, sdjnwangxiaoming@126.com
- Recruiting
Gansu provincial center for disease control and prevention
Lanzhou, Gansu, 730099
Yanling Wang, 18189527633, wylxiao@126.com
- Recruiting
Tianjin Medical University
Tianjin, Tianjin Municipality, 300070
Wenxing Guo, Doctor, 18822024500, guowenxing@tmu.edu.cn
About this study
Official title: An Iodine Balance Study in the Elderly
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.
- Conditions
- Nutrition, Healthy
- Being tested
- Restrict subjects' intake of iodine-containing foods
- Keywords
- recommended intake of iodine, iodine balance study, thyroid diseases, elderly
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrict subjects' intake of iodine-containing foodsBehavioural
Replace subjects' iodized salt with non-iodized salt.
| Study group | Role | What they receive |
|---|---|---|
| Iodine intake intervention balance experiment | Other | Replace subjects' iodized salt with non-iodized salt. Receives: Behavioral: Restrict subjects' intake of iodine-containing foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine intake
Daily iodine intake includes dietary iodine intake and drinking water iodine intake.
Measured: 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.
Measured: Each phase of the iodine balance study lasts 4 to 10 days.
Secondary outcomes (5)
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.
Measured: Within one week before the start of the experiment.
thyroid volumn
Thyroid volume was measured using thyroid B-ultrasound.
Measured: Within one week before the start of the experiment.
salivary iodine
Every time the subject urinates, 2ml of saliva is collected.
Measured: 4 to 10 days
blood pressure
Subjects had their blood pressure measured before and after the study.
Measured: Within one week before the start of the experiment.
fasting blood glucose
Subjects had their fasting blood glucose measured before and after the study.
Measured: Within one week before the start of the experiment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Apr 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenxing Guo
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Gansu Provincial Centre for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Wenxing Guo, Tianjin Medical University
- Investigators
- Wenxing Guo, Study chair, Department of Nutrition and Food Hygiene, School of Public Health, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218043
- Sponsor's protocol ID
- 82204041-NSFC
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the study are available from the project leader upon reasonable request.
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 25591468Farebrother 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 30891786Dold 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 27465383Malvaux 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 5762324Ingenbleek 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 4208456Chinese 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 32624007Tan 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Iodine Balance Study in the Elderly
- ClinicalTrials.gov ID
- NCT06218043
- Acronym / sponsor ID
- 82204041-NSFC
- Conditions
- Nutrition, Healthy
- Keywords
- recommended intake of iodine, iodine balance study, thyroid diseases, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wenxing GuoUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Gansu Provincial Centre for Disease Control and Prevention
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Iodine intake intervention balance experiment | Other | Behavioral: Restrict subjects' intake of iodine-containing foodsReplace subjects' iodized salt with non-iodized salt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 and above;
- at least 5 years of local residence.
Key exclusion criteria (5 listed)
- family genetic diseases；
- special dietary habits；
- taking iodine-containing drugs or supplements；
- metabolic diseases;
- thyroid diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrict subjects' intake of iodine-containing foodsReplace subjects' iodized salt with non-iodized salt. | Behavioural | Iodine intake intervention balance experiment |
Primary outcome
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.
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.
5 secondary outcomes
thyroid function indexes
Time frame: Within one week before the start of the experiment.
thyroid volumn
Time frame: Within one week before the start of the experiment.
salivary iodine
Time frame: 4 to 10 days
blood pressure
Time frame: Within one week before the start of the experiment.
fasting blood glucose
Time frame: Within one week before the start of the experiment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 25591468Zimmermann 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.
- Background: PubMed 30891786Farebrother 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.
- Background: PubMed 27465383Dold 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.
- Background: PubMed 5762324Malvaux 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.
- Background: PubMed 4208456Ingenbleek 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.
- BackgroundChinese Nutrition Society. Chinese Dietary Reference Intakes. Beijing, People's Medical Publishing House. 2014: 230-237. Chinese.
- Background: PubMed 32624007Yang 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.
- Background: PubMed 30526700Tan 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.
- Individual participant dataSharing planned: No. The data of the study are available from the project leader upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenxing Guo study chair
Department of Nutrition and Food Hygiene, School of Public Health, Tianjin Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrict subjects' intake of iodine-containing foods in people with Nutrition, Healthy, run by Wenxing Guo at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenxing Guo, doctor (18822024500, guowenxing@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iodine intake (time frame: Each phase of the iodine balance study lasts 4 to 10 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218043, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.