Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06540469

Iodine Supplementation in Graves' Hyperthyroidism

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Iodine Supplementation in Whole Course of Treatment with ATDs

Dietary Supplement

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 Supplementation During Maintenance Treatment with ATDs

Dietary Supplement

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 in Whole Course of Treatment with ATDs

Dietary Supplement

Iodine restriction (non-iodized salt and low iodine diet) will be demanded from ATDs treatment starting until 1 year after ATDs withdrawal.

anti-Thyroid Drugs

Drug

Individualized methimazole (MMI)

Primary outcomes

  1. Remission rate of hyperthyroidism

    Time frame: 30 months

Secondary outcomes

  1. Duration from initiation to withdrawal of ATDs

    Time frame: 18 months

  2. Duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization

    Time frame: 18 months

  3. Duration from initiation of ATDs to serum FT3 and FT4 normalization

    Time frame: 18 months

  4. Quality of life (QOL) in patients with Graves' hyperthyroidism

    Time frame: 30 months

  5. Adverse effects rate of ATDs treatment

    Time frame: 18 months

  6. Duration from initiation of ATDs to serum negative TRAb is first measured

    Time frame: 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Haiqing Zhang

CONTACT

[email protected]

+86531-68776383

Meng Zhao

CONTACT

[email protected]

+86531-68776383

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Collaborators

  • First Hospital of China Medical University
  • The Second Affiliated Hospital of Harbin Medical University

Registry information

Official study title

Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves' Hyperthyroidism: a Prospective Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.