Radioactive Iodine-Induced Hypothyroidism in Graves Disease PatientsNCT05643365
Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
An observational study of Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease. Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients
- What is being tested?
- Radioactive Iodine therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2013to 1 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All thyrotoxic patients treated with RAI
Who may be able to join
- Graves' disease patients after one year of RAI therapy .
- Suppressed serum thyrotropin (TSH) <0.55 µU/ml , elevated serum free triiodothyronine (FT3) > 6.5 pmol/L , free thyroxin FT4 >22.7 pmol/L .
Who cannot join
- Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
- Thyroid cancer
- Recurrent GD
- Previous Thyroid surgery
- Patients can't complete the follow -up within 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nuclear medicine unit, department of clinical oncology and nuclear medicine, Assiut university hospital
Asyut
About this study
The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.
Read the detailed description
Hyperthyroidism is a clinical syndrome caused by increased thyroid hormone in the blood, it can lead to multiple complications, including cardiac, hepatic, and hematologic system complications. More than 80% of hyperthyroidism are caused by Graves' disease (GD). 3% of women and 0.5% of men may suffer GD in their lifetime [1].
Radioactive iodine (RAI) therapy is an important treatment option for Graves' disease (GD), the main side effect of RAI treatment is hypothyroidism, and the factors resulting in hypothyroidism are still controversial [2]. Male gender, smaller thyroid weight, higher thyroid-stimulating hormone, and smaller thyroid volume are Suggested to be the main risk factors for early hypothyroidism [2]-[3].
- Being tested
- Radioactive Iodine therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Iodine therapyRadiation
All the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption.
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroidism | decreased hormone levels (FT3 < 3.5 pmol/L, FT4 < 11.5 pmol/L, TSH > 4.78 μU/mL) and symptoms of hypothyroidism within 6 months' follow-up. Receives: Radiation: Radioactive Iodine therapy | |
| Euthyroidism | normal hormone levels (FT3 3.5 to 6.5 pmol/L, FT4 11.5 to 22.7 pmol/L, TSH 0.55 to 4.78 μU/mL), and no symptoms of hyperthyroidism after 6 months' follow-up Receives: Radiation: Radioactive Iodine therapy | |
| Hyperthyroidism | increased hormone levels (FT3 > 6.5 pmol/L, FT4 > 22.7 pmol/L, TSH < 0.55 μU/mL) and symptoms of hyperthyroidism after 6 months' follow-up Receives: Radiation: Radioactive Iodine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive factors of early hypothyroidism after RAI therapy
Retrospective study from 2013 to 2022 to analyze the correlation between clinical, demographic\& and laboratory data and incidence of hypothyroidism by measuring thyroid function tests
Measured: 1 year
Secondary outcomes (1)
the incidence of hypothyroidism within 1 year
To detect the frequency of hypothyroidism after RAI and when it is most likely occur after 6 months or one year
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jan 2013
- Primary completion1 Nov 2022
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radioactive Iodine-Induced Hypothyroidism in Graves Disease PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdel-Baset Ahmed Ali Alsanory, Assiut University
- Investigators
- Hemat A Mahmoud, M.D, Study director, LecturerHanan G Mostafa, M.D, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643365
- Sponsor's protocol ID
- Hypothyroidism after RAI
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
PubMed 27797318Hu RT, Liu DS, Li B. Predictive factors for early hypothyroidism following the radioactive iodine therapy in Graves' disease patients. BMC Endocr Disord. 2020 May 29;20(1):76. doi: 10.1186/s12902-020-00557-w.
PubMed 32471411Demir BK, Karakilic E, Saygili ES, Araci N, Ozdemir S. Predictors of Hypothyroidism Following Empirical Dose Radioiodine in Toxic Thyroid Nodules: Real-Life Experience. Endocr Pract. 2022 Aug;28(8):749-753. doi: 10.1016/j.eprac.2022.05.001. Epub 2022 May 7.
PubMed 35537668
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
- ClinicalTrials.gov ID
- NCT05643365
- Acronym / sponsor ID
- Hypothyroidism after RAI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Dec 2022 (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.
The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.
Detailed description
Hyperthyroidism is a clinical syndrome caused by increased thyroid hormone in the blood, it can lead to multiple complications, including cardiac, hepatic, and hematologic system complications. More than 80% of hyperthyroidism are caused by Graves' disease (GD). 3% of women and 0.5% of men may suffer GD in their lifetime [1].
Radioactive iodine (RAI) therapy is an important treatment option for Graves' disease (GD), the main side effect of RAI treatment is hypothyroidism, and the factors resulting in hypothyroidism are still controversial [2]. Male gender, smaller thyroid weight, higher thyroid-stimulating hormone, and smaller thyroid volume are Suggested to be the main risk factors for early hypothyroidism [2]-[3].
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypothyroidism | – | Radiation: Radioactive Iodine therapydecreased hormone levels (FT3 < 3.5 pmol/L, FT4 < 11.5 pmol/L, TSH > 4.78 μU/mL) and symptoms of hypothyroidism within 6 months' follow-up. |
| Euthyroidism | – | Radiation: Radioactive Iodine therapynormal hormone levels (FT3 3.5 to 6.5 pmol/L, FT4 11.5 to 22.7 pmol/L, TSH 0.55 to 4.78 μU/mL), and no symptoms of hyperthyroidism after 6 months' follow-up |
| Hyperthyroidism | – | Radiation: Radioactive Iodine therapyincreased hormone levels (FT3 > 6.5 pmol/L, FT4 > 22.7 pmol/L, TSH < 0.55 μU/mL) and symptoms of hyperthyroidism after 6 months' follow-up |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All thyrotoxic patients treated with RAI
Key inclusion criteria (2 listed)
- Graves' disease patients after one year of RAI therapy .
- Suppressed serum thyrotropin (TSH) <0.55 µU/ml , elevated serum free triiodothyronine (FT3) > 6.5 pmol/L , free thyroxin FT4 >22.7 pmol/L .
Key exclusion criteria (5 listed)
- Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
- Thyroid cancer
- Recurrent GD
- Previous Thyroid surgery
- Patients can't complete the follow -up within 6 months.
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 |
|---|---|---|
| Radioactive Iodine therapyAll the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption. | Radiation | Euthyroidism, Hyperthyroidism, Hypothyroidism |
Primary outcome
predictive factors of early hypothyroidism after RAI therapy
Time frame: 1 year
Retrospective study from 2013 to 2022 to analyze the correlation between clinical, demographic\& and laboratory data and incidence of hypothyroidism by measuring thyroid function tests
1 secondary outcome
the incidence of hypothyroidism within 1 year
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 27797318Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
- Background: PubMed 32471411Hu RT, Liu DS, Li B. Predictive factors for early hypothyroidism following the radioactive iodine therapy in Graves' disease patients. BMC Endocr Disord. 2020 May 29;20(1):76. doi: 10.1186/s12902-020-00557-w.
- Background: PubMed 35537668Demir BK, Karakilic E, Saygili ES, Araci N, Ozdemir S. Predictors of Hypothyroidism Following Empirical Dose Radioiodine in Toxic Thyroid Nodules: Real-Life Experience. Endocr Pract. 2022 Aug;28(8):749-753. doi: 10.1016/j.eprac.2022.05.001. Epub 2022 May 7.
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. This study is not recruiting at the moment.
Hemat A Mahmoud, M.D study director
Lecturer
Hanan G Mostafa, M.D study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya A Alsanory, Master (00201063490867, ayota17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive factors of early hypothyroidism after RAI therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643365, which also lists 3 linked publications.
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 12 Oct 2023.