Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease
NCT ID: NCT05643365
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2013-01-01
2023-12-01
Brief Summary
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Detailed Description
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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 \[2\]-\[3\].
Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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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.
Radioactive Iodine therapy
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.
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
Radioactive Iodine therapy
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.
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
Radioactive Iodine therapy
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.
Interventions
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Radioactive Iodine therapy
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.
Eligibility Criteria
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Inclusion Criteria
2. Suppressed serum thyrotropin (TSH) \<0.55 µU/ml , elevated serum free triiodothyronine (FT3) \> 6.5 pmol/L , free thyroxin FT4 \>22.7 pmol/L .
Exclusion Criteria
2. Thyroid cancer
3. Recurrent GD
4. Previous Thyroid surgery
5. Patients can't complete the follow -up within 6 months.
13 Years
70 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Aya Abdel-Baset Ahmed Ali Alsanory
Resident in nuclear medicine departement (South Egypt Cancer institute)
Principal Investigators
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Hemat A Mahmoud, M.D
Role: STUDY_DIRECTOR
Lecturer
Hanan G Mostafa, M.D
Role: STUDY_CHAIR
Professor
Locations
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Nuclear medicine unit, department of clinical oncology and nuclear medicine, Assiut university hospital
Asyut, , Egypt
Countries
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Central Contacts
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References
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Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.
Hu 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.
Demir 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.
Other Identifiers
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Hypothyroidism after RAI
Identifier Type: -
Identifier Source: org_study_id
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