An observational study in Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 13 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Assiut University · Observational
The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.
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].
150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 300 is above the median of 110 across 57 observational studies indexed under Graves Disease.
Browse Graves Disease studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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All thyrotoxic patients treated with RAI
Exclusion Criteria:
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.
Radiation: Radioactive Iodine therapy
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
Radiation: Radioactive Iodine therapy
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
Radiation: 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.
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
Time frame: 1 year
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
Time frame: 10 years
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Assiut University