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

NCT ID: NCT05643365

Last Updated: 2023-10-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2023-12-01

Brief Summary

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

Detailed Description

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

Conditions

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Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type RADIATION

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

Intervention Type RADIATION

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

Intervention Type RADIATION

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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aya Abdel-Baset Ahmed Ali Alsanory

Resident in nuclear medicine departement (South Egypt Cancer institute)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aya A Alsanory, Master

Role: CONTACT

00201063490867

Esraa R Hassan, M.D

Role: CONTACT

00201098589000

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.

Reference Type BACKGROUND
PMID: 27797318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32471411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35537668 (View on PubMed)

Other Identifiers

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Hypothyroidism after RAI

Identifier Type: -

Identifier Source: org_study_id

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