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Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease

A

Assiut University

Status

Enrolling

Conditions

Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients

Treatments

Radiation: Radioactive Iodine therapy

Study type

Observational

Funder types

Other

Identifiers

NCT05643365
Hypothyroidism after RAI

Details and patient eligibility

About

The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.

Full 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].

Enrollment

300 estimated patients

Sex

All

Ages

13 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Graves' disease patients after one year of RAI therapy .
  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

  1. Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
  2. Thyroid cancer
  3. Recurrent GD
  4. Previous Thyroid surgery
  5. Patients can't complete the follow -up within 6 months.

Trial design

300 participants in 3 patient groups

Hypothyroidism
Description:
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.
Treatment:
Radiation: Radioactive Iodine therapy
Euthyroidism
Description:
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
Treatment:
Radiation: Radioactive Iodine therapy
Hyperthyroidism
Description:
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
Treatment:
Radiation: Radioactive Iodine therapy

Trial contacts and locations

1

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Central trial contact

Esraa R Hassan, M.D; Aya A Alsanory, Master

Data sourced from clinicaltrials.gov

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