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

ID: NCT03444246
Status: Not yet recruiting
Phase: N/A
Start Date: March 01, 2018
First Submitted: February 06, 2018
Last Updated: February 21, 2018
Results: N/A
Organization: Xijing Hospital
Sponsors & Collaborators: Xijing Hospital
Location: China
Conditions: Hyperthyroidism
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Study Description

Brief 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.

Detailed Description

Condition or disease Intervention/treatment Phase

Hyperthyroidism

Dietary Supplement: Iodine free diet group
Other Names
Dietary Supplement: Normal iodine diet group
Other Names
N/A

Tracking Information

First Submitted DateFebruary 06, 2018
Last Update Posted DateFebruary 21, 2018
Anticipated Start DateMarch 01, 2018
Anticipated Completion DateJune 01, 2019
Anticipated Primary Completion DateMarch 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
Official TitleA Parallel, Double-blind, Randomized Controlled Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
Brief 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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
60
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Prevention
Conditions
Hyperthyroidism
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
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.

Other Names
Study Groups/Cohorts
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.

Normal iodine diet group
The arm with iodized salt,the subject in the control group were consumed with iodized salt within six months.

Study Arms
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.

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 : 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.

Arm Intervention/Treatment
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
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 : Normal iodine diet group
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

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment60
Completion DateJune 01, 2019
Eligibility Criteria: 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
GenderAll
Age18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03444246
Other Study ID Numbers
KY20172032-1
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Xijing Hospital
Collaborators
Not Available
Investigators
Not Available