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

NCT ID: NCT03444246

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-06-01

Brief Summary

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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

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Conditions

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Hyperthyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Iodine free diet group

Intervention Type DIETARY_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 group

Intervention Type DIETARY_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 group

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

Group Type ACTIVE_COMPARATOR

Normal iodine diet group

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Qiuhe Ph.D Ji, Ph.D.,M.D.

Role: CONTACT

(86)13700291268

Jie Ph.D Zhou, M.D.

Role: CONTACT

‭(86)13992865056

Other Identifiers

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KY20172032-1

Identifier Type: -

Identifier Source: org_study_id

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