Iodine Supplementation in Graves' Hyperthyroidism
Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves' Hyperthyroidism: a Prospective Randomized Controlled Trial
1 other identifier
interventional
315
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
August 6, 2024
August 1, 2024
3 years
July 30, 2024
August 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission rate of hyperthyroidism
30 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Iodine Supplementation in Whole Course of Treatment with ATDs
EXPERIMENTALIodine Supplementation During Maintenance Treatment with ATDs
EXPERIMENTALIodine Restriction in Whole Course of Treatment with ATDs
OTHERInterventions
Moderate iodine supplementation (150μg iodine per day, equivalently 7-9g iodized salt per day) will be taken from ATDs treatment starting until 1 year after ATDs withdrawal.
Iodine restriction (non-iodized salt and low iodine diet) will be demanded at the early course of ATDs treatment, and moderate iodine supplementation (150μg iodine per day, equivalently 7-9g iodized salt per day) will be taken when the ATDs dose is titrated down to a maintenance level until 1 year after ATDs withdrawal.
Iodine restriction (non-iodized salt and low iodine diet) will be demanded from ATDs treatment starting until 1 year after ATDs withdrawal.
Individualized methimazole (MMI)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 6, 2024
Study Start
August 1, 2024
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2028
Last Updated
August 6, 2024
Record last verified: 2024-08