A Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
A Parallel, Double-blind, Randomized Controlled Trial for the Evaluation of the Treatment and Outcome of Hyperthyroidism With Iodized Salt and Non Iodized Salt
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFebruary 23, 2018
December 1, 2017
1 year
February 6, 2018
February 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.
Study Arms (2)
Iodine free diet group
EXPERIMENTALThe 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 COMPARATORThe arm with iodized salt，the subject in the control group were consumed with iodized salt within six months.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2018
First Posted
February 23, 2018
Study Start
March 1, 2018
Primary Completion
March 1, 2019
Study Completion
June 1, 2019
Last Updated
February 23, 2018
Record last verified: 2017-12