Status:
NOT_YET_RECRUITING
Iodine Supplementation in Graves' Hyperthyroidism
Lead Sponsor:
Shandong Provincial Hospital
Collaborating Sponsors:
First Hospital of China Medical University
The Second Affiliated Hospital of Harbin Medical University
Conditions:
Graves Disease
Hyperthyroidism
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In China, the morbidity of thyroid diseases is high and the harm is serious. Iodine is closely related to thyroid diseases. It should be paid attention to guide patients to supplement iodine scientifi...
Eligibility Criteria
Inclusion
- patients newly diagnosed with Graves' hyperthyroidism and not treated; or
- patients diagnosed with Graves' hyperthyroidism and treated with ATDs regularly less than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive; or
- patients diagnosed with Graves' hyperthyroidism and not regularly treated with ATDs more than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive.
Exclusion
- thyroid enlargement of grade 3;
- serum TRAb is measured above 40IU/L;
- moderate or severe thyroid-associated eye diseases;
- hepatic disease history including chronic active hepatitis, severe hepatic dysfunction, liver cirrhosis, etc., and serum transaminase level is 3 times higher than the upper normal limit and/or total bilirubin level is higher than 34.2μmol/L with hepatic protective drugs;
- history of moderate-to-severe or end-stage renal disease: eGFR\<60mL/min/1.73m2 with simplified MDRD formula;
- serum WBC\<3.0×109／L or neutrophil count\<1.5×109／L;
- history of severe cardiocerebrovascular disease, digestive disease, hematopoietic system disease, other autoimmune diseases in addition to Graves' hyperthyroidism, tumors, psychosis, etc.;
- blood pressure\>180/100mmHg with regular antihypertensive drugs treatment;
- severe comorbidities and complications of hyperthyroidism with ATDs treatment;
- history of multiple drug allergies;
- a family planning plan in 3 years.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT06540469
Start Date
August 1 2024
End Date
July 31 2028
Last Update
August 6 2024
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