Iodine Supplementation in Graves' Hyperthyroidism

Launched by SHANDONG PROVINCIAL HOSPITAL · Aug 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different amounts of iodine might affect people with Graves' hyperthyroidism, a condition where the thyroid gland is overactive. The research aims to find out whether taking iodine supplements during treatment helps patients feel better and achieve normal thyroid function more quickly compared to those who limit their iodine intake. The trial will involve 315 participants from three different centers in China, who will be randomly divided into three groups: one group will receive iodine supplements throughout their treatment, another group will get iodine during the maintenance phase, and the third group will restrict iodine intake.

To be eligible for this study, participants should be newly diagnosed with Graves' hyperthyroidism or have been treated for less than three months with a specific type of medication called antithyroid drugs (ATDs). They must also have certain thyroid hormone levels that indicate hyperthyroidism. Throughout the study, participants can expect to have their thyroid function monitored at various intervals, and their overall quality of life will be assessed. This trial is important because it seeks to clarify how iodine affects the treatment of hyperthyroidism, which could lead to better care for patients in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. patients newly diagnosed with Graves' hyperthyroidism and not treated; or
• • 2. 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
• • 3. 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 Criteria:
• • 1. thyroid enlargement of grade 3;
• • 2. serum TRAb is measured above 40IU/L;
• • 3. moderate or severe thyroid-associated eye diseases;
• • 4. 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;
• • 5. history of moderate-to-severe or end-stage renal disease: eGFR\<60mL/min/1.73m2 with simplified MDRD formula;
• • 6. serum WBC\<3.0×109／L or neutrophil count\<1.5×109／L;
• • 7. history of severe cardiocerebrovascular disease, digestive disease, hematopoietic system disease, other autoimmune diseases in addition to Graves' hyperthyroidism, tumors, psychosis, etc.;
• • 8. blood pressure\>180/100mmHg with regular antihypertensive drugs treatment;
• • 9. severe comorbidities and complications of hyperthyroidism with ATDs treatment;
• • 10. history of multiple drug allergies;
• • 11. a family planning plan in 3 years.