Iodine Supplementation in Graves' Hyperthyroidism
NCT Number: NCT06540469
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graves Disease|Hyperthyroidism
Interventions: DIETARY_SUPPLEMENT: Iodine Supplementation in Whole Course of Treatment with ATDs|DIETARY_SUPPLEMENT: Iodine Supplementation During Maintenance Treatment with ATDs|DIETARY_SUPPLEMENT: Iodine Restriction in Whole Course of Treatment with ATDs|DRUG: anti-Thyroid Drugs
Sponsor: Shandong Provincial Hospital
Collaborators: First Hospital of China Medical University|The Second Affiliated Hospital of Harbin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 315
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-31

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 scientifically. Thyroid iodine uptake in hyperthyroidism patients is enhanced, and patients are generally advised to limit iodine intake in clinical practice. However, recent studies suggest that there is no definite conclusion on whether patients with hyperthyroidism should strictly limit iodine intake. The purpose of this study is to establish a national multi-center iodine intervention cohort for patients with Graves' hyperthyroidism, identify the effects of different iodine intake on hyperthyroidism, and establish iodine intervention program for hyperthyroidism. This study is a multicenter, prospective, open-level, randomized, controlled, parallel group clinical trial with a total sample size of 315 cases, a total of 3 participating units, each of which completed 105 cases. All subjects meeting the inclusion criteria were completely randomized in each center according to the random procedure with a probability of 1:1:1: ① Iodine Supplementation in Whole Course of Treatment with ATDs; ② Iodine Supplementation During Maintenance Treatment with ATDs; ③ Iodine Restriction in Whole Course of Treatment with ATDs. Information was collected before ATD treatment, at 3 months, 6 months, 12 months, 18 months (withdrawal), 6 months and 12 months after ATDs withdrawal. The primary purpose of this study is to analyze the difference in remission rate of hyperthyroidism between different iodine nutritional interventions. At the same time, the differences of duration from initiation to withdrawal of ATDs, duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization, duration from initiation of ATDs to serum FT3 and FT4 normalization, quality of life (QOL) in patients with Graves' hyperthyroidism, adverse effects rate of ATDs treatment, duration from initiation of ATDs to serum negative TRAb is first measured were observed.

Primary Outcome Measures: Remission rate of hyperthyroidism, 30 months
Secondary Outcome Measures: Duration from initiation to withdrawal of ATDs, 18 months|Duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization, 18 months|Duration from initiation of ATDs to serum FT3 and FT4 normalization, 18 months|Quality of life (QOL) in patients with Graves' hyperthyroidism, 30 months|Adverse effects rate of ATDs treatment, 18 months|Duration from initiation of ATDs to serum negative TRAb is first measured, 18 months