Graves DiseaseNCT06540469
Iodine Supplementation in Graves' Hyperthyroidism
A study testing Iodine Supplementation in Whole Course of Treatment with ATDs, Iodine Supplementation During Maintenance Treatment with ATDs and Iodine Restriction in Whole Course of Treatment with ATDs in people with Graves Disease and Hyperthyroidism, run by Shandong Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graves Disease, Hyperthyroidism
- What is being tested?
- Iodine Supplementation in Whole Course of Treatment with ATDs, Iodine Supplementation During Maintenance Treatment with ATDs and Iodine Restriction in Whole Course of Treatment with ATDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves' Hyperthyroidism: a Prospective Randomized Controlled Trial
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.
- Conditions
- Graves Disease, Hyperthyroidism
- Being tested
- Iodine Supplementation in Whole Course of Treatment with ATDs, Iodine Supplementation During Maintenance Treatment with ATDs, Iodine Restriction in Whole Course of Treatment with ATDs, anti-Thyroid Drugs
- Keywords
- Graves' Disease, Hyperthyroidism, Iodine Supplementation, Anti-Thyroid Drug
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine Supplementation in Whole Course of Treatment with ATDsDietary 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 ATDsDietary 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 ATDsDietary 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 DrugsDrug
Individualized methimazole (MMI)
| Study group | Role | What they receive |
|---|---|---|
| Iodine Supplementation in Whole Course of Treatment with ATDs | Experimental | Not described Receives: Dietary Supplement: Iodine Supplementation in Whole Course of Treatment with ATDs; Drug: anti-Thyroid Drugs |
| Iodine Supplementation During Maintenance Treatment with ATDs | Experimental | Not described Receives: Dietary Supplement: Iodine Supplementation During Maintenance Treatment with ATDs; Drug: anti-Thyroid Drugs |
| Iodine Restriction in Whole Course of Treatment with ATDs | Other | Not described Receives: Dietary Supplement: Iodine Restriction in Whole Course of Treatment with ATDs; Drug: anti-Thyroid Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of hyperthyroidism
Measured: 30 months
Secondary outcomes (6)
Duration from initiation to withdrawal of ATDs
Measured: 18 months
Duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization
Measured: 18 months
Duration from initiation of ATDs to serum FT3 and FT4 normalization
Measured: 18 months
Quality of life (QOL) in patients with Graves' hyperthyroidism
Measured: 30 months
Adverse effects rate of ATDs treatment
Measured: 18 months
Duration from initiation of ATDs to serum negative TRAb is first measured
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- First Hospital of China Medical University, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Hai-qing Zhang, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540469
- Sponsor's protocol ID
- 20240521
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves' Hyperthyroidism: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06540469
- Acronym / sponsor ID
- 20240521
- Conditions
- Graves Disease, Hyperthyroidism
- Keywords
- Graves' Disease, Hyperthyroidism, Iodine Supplementation, Anti-Thyroid Drug
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- First Hospital of China Medical University, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iodine Supplementation in Whole Course of Treatment with ATDs | Experimental | Dietary Supplement: Iodine Supplementation in Whole Course of Treatment with ATDs, Drug: anti-Thyroid Drugs |
| Iodine Supplementation During Maintenance Treatment with ATDs | Experimental | Dietary Supplement: Iodine Supplementation During Maintenance Treatment with ATDs, Drug: anti-Thyroid Drugs |
| Iodine Restriction in Whole Course of Treatment with ATDs | Other | Dietary Supplement: Iodine Restriction in Whole Course of Treatment with ATDs, Drug: anti-Thyroid Drugs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine Supplementation in Whole Course of Treatment with ATDsModerate 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. | Dietary supplement | Iodine Supplementation in Whole Course of Treatment with ATDs |
| Iodine Supplementation During Maintenance Treatment with ATDsIodine 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. | Dietary supplement | Iodine Supplementation During Maintenance Treatment with ATDs |
| Iodine Restriction in Whole Course of Treatment with ATDsIodine restriction (non-iodized salt and low iodine diet) will be demanded from ATDs treatment starting until 1 year after ATDs withdrawal. | Dietary supplement | Iodine Restriction in Whole Course of Treatment with ATDs |
| anti-Thyroid DrugsIndividualized methimazole (MMI) | Drug | Iodine Restriction in Whole Course of Treatment with ATDs, Iodine Supplementation During Maintenance Treatment with ATDs, Iodine Supplementation in Whole Course of Treatment with ATDs |
Primary outcome
Remission rate of hyperthyroidism
Time frame: 30 months
6 secondary outcomes
Duration from initiation to withdrawal of ATDs
Time frame: 18 months
Duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization
Time frame: 18 months
Duration from initiation of ATDs to serum FT3 and FT4 normalization
Time frame: 18 months
Quality of life (QOL) in patients with Graves' hyperthyroidism
Time frame: 30 months
Adverse effects rate of ATDs treatment
Time frame: 18 months
Duration from initiation of ATDs to serum negative TRAb is first measured
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine Supplementation in Whole Course of Treatment with ATDs, Iodine Supplementation During Maintenance Treatment with ATDs and Iodine Restriction in Whole Course of Treatment with ATDs in people with Graves Disease and Hyperthyroidism, run by Shandong Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Zhao (+86531-68776383, zjsylpzm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of hyperthyroidism (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.