HyperthyroidismNCT03444246
A Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
A study testing Iodine free diet group and Normal iodine diet group in people with Hyperthyroidism, run by Xijing Hospital at 1 site in China.
Trial summary
To clarify the influence of iodine intake in salt on the incidence and treatment of hyperthyroidism patients, so as to provide theoretical basis for accurate formulation of iodine intake in salt, and provide strategies for effective prevention and control of hyperthyroidism. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperthyroidism
- What is being tested?
- Iodine free diet group and Normal iodine diet group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jun 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sign informed consent before any research procedure is carried out
- men or women aged 18-65 (equal) at the age of 1.
- had been diagnosed as Graves hyperthyroidism
- patients with hyperthyroidism who had not been treated with drugs or stopped taking medicine for more than 3 months
- reduction to the current dose of hyperthyroidism for more than 2 months
Who cannot join
- during the period of pregnancy and lactation, those who plan to be pregnant during the study are not granted medical permission.
- Effective contraceptives
- for the last 1 months or the need for long-term use of amiodarone
- the history of anaphylaxis (such as systemic anaphylaxis, vasoedema, epidermal exfoliation) Etc.)
- consecutive use of beta receptor blockers for the last 2 weeks
- over the past six months, systemic use of corticosteroids (oral or intravenous) is continuous More than 7 days
Show all 9Show fewer
- there was an obvious liver disease, showing one of the following cases: two consecutive weeks before A. visits.
- It was confirmed that the measurements of AST or ALT were more than 3 times higher than the highest normal value (local data).
- bilirubin synthesis and / or excretion disorders (such as hyperbilirubinemia), and other Decompensated liver diseases such as coagulation disorders, hepatic encephalopathy, hypoproteinemia, ascites, and esophagus Bleeding from varicose veins. C. acute viral, active, alcoholic, and alcoholic Other types of hepatitis 7 visits for 4 weeks before the 1 (or the local data), leukopenia (less than 3 * 10 9 /L) B/ 0 edition of the First Affiliated Hospital of The Fourth Military Medical University The First Affiliated Hospital, the Fourth Military Medical University B/0 Edition Seventh pages / 13 Pages Or neutropenia (less than 1.5 * 10 9 /L) 8 congestive heart failure at grade III or IV of the New York Heart Association (NYHA) 9 the past 3 months of visit to 1 had a major cardiovascular history, defined as: myocardial infarction Plug and coronary angioplasty or bypass surgery, valvular disease or repair, instability Angina pectoris, transient ischemic attack, or cerebrovascular accident 10 non well controlled atrial fibrillation 11 diagnosis of malignant tumors over the past 5 years 12 history of medullary thyroid carcinoma 13 organ transplantation or AIDS history 14 severe exophthalmos has influenced visual acuity 15 over the last 12 months, there is a history of alcohol abuse or drug abuse
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, 710032
About this study
Official title: A Parallel, Double-blind, Randomized Controlled Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
To clarify the influence of iodine intake in salt on the incidence and treatment of hyperthyroidism patients, so as to provide theoretical basis for accurate formulation of iodine intake in salt, and provide strategies for effective prevention and control of hyperthyroidism.
- Conditions
- Hyperthyroidism
- Being tested
- Iodine free diet group, Normal iodine diet group
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine free diet groupDietary supplement
120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months.
Normal iodine diet groupDietary supplement
120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Iodine free diet group | Experimental | The arm with non iodized salt，the subject in the non iodized salt group used the iodized salt for the first three months, and the iodized salt was changed after three months. Receives: Dietary Supplement: Iodine free diet group; Dietary Supplement: Normal iodine diet group |
| Normal iodine diet group | Active comparator | The arm with iodized salt，the subject in the control group were consumed with iodized salt within six months. Receives: Dietary Supplement: Normal iodine diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the recurrence rate of hyperthyroidism in the two groups
The patients were randomly divided into the non-iodine diet group, the normal iodine diet group, and the two groups were given routine anti-thyroid medication for 6 months.
Measured: The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444246
- Sponsor's protocol ID
- KY20172032-1
- Status last verified
- Dec 2017
- First submitted
- 6 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel, Double-blind, Randomized Controlled Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
- ClinicalTrials.gov ID
- NCT03444246
- Acronym / sponsor ID
- KY20172032-1
- Conditions
- Hyperthyroidism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 23 Feb 2018 (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.
To clarify the influence of iodine intake in salt on the incidence and treatment of hyperthyroidism patients, so as to provide theoretical basis for accurate formulation of iodine intake in salt, and provide strategies for effective prevention and control of hyperthyroidism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine free diet group | Experimental | Dietary Supplement: Iodine free diet group, Dietary Supplement: Normal iodine diet groupThe arm with non iodized salt，the subject in the non iodized salt group used the iodized salt for the first three months, and the iodized salt was changed after three months. |
| Normal iodine diet group | Active comparator | Dietary Supplement: Normal iodine diet groupThe arm with iodized salt，the subject in the control group were consumed with iodized salt within six months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- sign informed consent before any research procedure is carried out
- men or women aged 18-65 (equal) at the age of 1.
- had been diagnosed as Graves hyperthyroidism
- patients with hyperthyroidism who had not been treated with drugs or stopped taking medicine for more than 3 months
- reduction to the current dose of hyperthyroidism for more than 2 months
Key exclusion criteria (9 listed)
- during the period of pregnancy and lactation, those who plan to be pregnant during the study are not granted medical permission.
- Effective contraceptives
- for the last 1 months or the need for long-term use of amiodarone
- the history of anaphylaxis (such as systemic anaphylaxis, vasoedema, epidermal exfoliation) Etc.)
- consecutive use of beta receptor blockers for the last 2 weeks
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 |
|---|---|---|
| Iodine free diet group120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months. | Dietary supplement | Iodine free diet group |
| Normal iodine diet group120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months. | Dietary supplement | Iodine free diet group, Normal iodine diet group |
Primary outcome
Compare the recurrence rate of hyperthyroidism in the two groups
Time frame: The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.
The patients were randomly divided into the non-iodine diet group, the normal iodine diet group, and the two groups were given routine anti-thyroid medication for 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine free diet group and Normal iodine diet group in people with Hyperthyroidism, run by Xijing Hospital at 1 site 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 5 inclusion and 9 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qiuhe Ph.D Ji, Ph.D.,M.D. ((86)13700291268, qiuheji@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the recurrence rate of hyperthyroidism in the two groups (time frame: The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.