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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05643365
Enrollment
300
Registered
2022-12-08
Start date
2013-01-01
Completion date
2023-12-01
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients

Brief summary

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 \[2\]-\[3\].

Interventions

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
predictive factors of early hypothyroidism after RAI therapy1 yearRetrospective study from 2013 to 2022 to analyze the correlation between clinical, demographic& and laboratory data and incidence of hypothyroidism by measuring thyroid function tests

Secondary

MeasureTime frameDescription
the incidence of hypothyroidism within 1 year10 yearsTo detect the frequency of hypothyroidism after RAI and when it is most likely occur after 6 months or one year

Countries

Egypt

Contacts

Primary ContactAya A Alsanory, Master
ayota17@gmail.com00201063490867
Backup ContactEsraa R Hassan, M.D
Esraaa.roshdy@yahoo.com00201098589000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026