ClinicalTrials.gg
Status unknownNCT03444246Updated Feb 23, 2018

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

An interventional study of Iodine free diet group and Normal iodine diet group in Hyperthyroidism, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperthyroidism

Browse trials for

03

In context

Hyperthyroidism

112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 61 interventional studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. sign 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

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

  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 (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 or ALT were more than 3 times higher than the highest normal value (local data).

B. 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 (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, , 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

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

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 · 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

Interventions

  • Dietary supplementIodine 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 supplementNormal 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.

06

What researchers measure

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.

    Time frame: The recurrence rate of hyperthyroidism in the two groups was compared after the first six months of the trial.

07

Study locations

1 site
  • Xijing Hospital, Fourth Military Medical university
    Xi'an, Shaanxi 710032, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03444246
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Mar 1, 2018 (estimated)
Primary completion
Mar 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Feb 23, 2018

Study contacts

Qiuhe Ph.D Ji, Ph.D.,M.D.
Contact
qiuheji@hotmail.com
(86)13700291268
Jie Ph.D Zhou, M.D.
Contact
zhoujie5056@163.com
‭(86)13992865056

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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