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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verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.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

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03

Who can participate

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

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

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

04

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.

05

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.

06

Study locations

1 site
  • Xijing Hospital, Fourth Military Medical university
    Xi'an, Shaanxi 710032, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

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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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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