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

Primary Purpose

Hyperthyroidism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iodine free diet group
Normal iodine diet group
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperthyroidism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital, Fourth Military Medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iodine free diet group

Normal iodine diet group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2018
Last Updated
February 21, 2018
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03444246
Brief Title
A Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iodine free diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal iodine diet group
Arm Type
Active Comparator
Arm Description
The arm with iodized salt,the subject in the control group were consumed with iodized salt within six months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Iodine free diet group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Normal iodine diet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare the recurrence rate of hyperthyroidism in the two groups
Description
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.
Time Frame
The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuhe Ph.D Ji, Ph.D.,M.D.
Phone
(86)13700291268
Email
qiuheji@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Ph.D Zhou, M.D.
Phone
‭(86)13992865056
Email
zhoujie5056@163.com
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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