Iodine DeficiencyNCT03279315
An Iodine Balance Experiment
A study testing iodized table salt, non-iodized table salt in people with Iodine Deficiency and Nutritional Requirements, run by Tianjin Medical University.
Trial summary
A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Nutritional Requirements
- What is being tested?
- iodized table salt, non-iodized table salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2014to 10 Mar 2017
- 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 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.
Who cannot join
- The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.
About this study
Official title: Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment
A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.
Read the detailed description
The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.
- Conditions
- Iodine Deficiency, Nutritional Requirements
- Being tested
- iodized table salt, non-iodized table salt
- Keywords
- Iodine, Balance experiment, EAR, Chinese women, Euthyroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodized table salt, non-iodized table saltDietary supplement
During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.
| Study group | Role | What they receive |
|---|---|---|
| experimental period | Experimental | the first period was with non-iodized salt, the second period was with iodized salt. Receives: Dietary Supplement: iodized table salt, non-iodized table salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total iodine intake and total iodine excretion
Iodine intake includes iodine from food, water and air (μg/d).
Measured: 12 days
Total iodine excretion
Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).
Measured: 12 days
urinary iodine concentration (UIC)
μg/L
Measured: At the beginning of the experiment
Thyroid function
FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)
Measured: At the beginning 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 posted12 Sep 2017
- Study start20 Nov 2014
- Primary completion19 Dec 2014
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iodine DeficiencyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants received a diet with iodized table salt or non-iodized table salt
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanqi Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279315
- Sponsor's protocol ID
- NSFC-31340033
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Tian X, Song Q, Wang W, Guo X, Cui T, Pan Z, Chen Y, Chen W, Tan L, Zhang W. Application and Comparison of Different Regression Models in Iodine Balance Experiment on Women of Childbearing Age and Pregnant Women. Biol Trace Elem Res. 2024 Jun;202(6):2474-2487. doi: 10.1007/s12011-023-03867-x. Epub 2023 Oct 9.
PubMed 37807000
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment
- ClinicalTrials.gov ID
- NCT03279315
- Acronym / sponsor ID
- NSFC-31340033
- Conditions
- Iodine Deficiency, Nutritional Requirements
- Keywords
- Iodine, Balance experiment, EAR, Chinese women, Euthyroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 19 Dec 2014 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 12 Sep 2017 (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.
A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.
Detailed description
The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants received a diet with iodized table salt or non-iodized table salt
| Arm | Type | Receives |
|---|---|---|
| experimental period | Experimental | Dietary Supplement: iodized table salt, non-iodized table saltthe first period was with non-iodized salt, the second period was with iodized salt. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.
Key exclusion criteria (1 listed)
- The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.
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 |
|---|---|---|
| iodized table salt, non-iodized table saltDuring the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. | Dietary supplement | experimental period |
Primary outcome
Total iodine intake and total iodine excretion
Time frame: 12 days
Iodine intake includes iodine from food, water and air (μg/d).
Total iodine excretion
Time frame: 12 days
Iodine excretion includes iodine excreted by urine, feces, sweat and breath (μg/d).
urinary iodine concentration (UIC)
Time frame: At the beginning of the experiment
μg/L
Thyroid function
Time frame: At the beginning of the experiment
FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Derived from this study: PubMed 37807000Wang Y, Tian X, Song Q, Wang W, Guo X, Cui T, Pan Z, Chen Y, Chen W, Tan L, Zhang W. Application and Comparison of Different Regression Models in Iodine Balance Experiment on Women of Childbearing Age and Pregnant Women. Biol Trace Elem Res. 2024 Jun;202(6):2474-2487. doi: 10.1007/s12011-023-03867-x. Epub 2023 Oct 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iodized table salt, non-iodized table salt in people with Iodine Deficiency and Nutritional Requirements, run by Tianjin Medical University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total iodine intake and total iodine excretion (time frame: 12 days). The study lists 4 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 NCT03279315, which also lists 1 linked publication.
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 12 Sep 2017.