A Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt

February 21, 2018 updated by: Xijing Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. sign informed consent before any research procedure is carried out
  2. men or women aged 18-65 (equal) at the age of 1.
  3. had been diagnosed as Graves hyperthyroidism
  4. patients with hyperthyroidism who had not been treated with drugs or stopped taking medicine for more than 3 months
  5. reduction to the current dose of hyperthyroidism for more than 2 months

Exclusion Criteria:

  1. during the period of pregnancy and lactation, those who plan to be pregnant during the study are not granted medical permission.

    Effective contraceptives

  2. for the last 1 months or the need for long-term use of amiodarone
  3. the history of anaphylaxis (such as systemic anaphylaxis, vasoedema, epidermal exfoliation) Etc.)
  4. consecutive use of beta receptor blockers for the last 2 weeks
  5. over the past six months, systemic use of corticosteroids (oral or intravenous) is continuous More than 7 days
  6. 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).

B. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Iodine free diet group
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.
Dietary supplement: Iodine free diet group
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.
Dietary supplement: Normal iodine diet group
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.
ACTIVE_COMPARATOR: Normal iodine diet group
The arm with iodized salt，the subject in the control group were consumed with iodized salt within six months.
Dietary supplement: Normal iodine diet group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20172032-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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