Comparative Study of Different I-131 Doses in Graves' Disease

The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02114619

Enrollment

450

Registered

2014-04-15

Start date

2013-05-31

Completion date

2016-12-31

Last updated

2014-04-15

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

Conditions

Graves' Disease

Keywords

radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose

Brief summary

Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.

Interventions

DRUGLow dose of I-131

We wil administer 100 micro currie of iodine per thyroid gram

DRUGIntermediate dose

We will administer 150 micro currie of iodine per thyroid gram

DRUGHigh dose

We will administer 200 micro currie of iodine per thyroid gram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion criteria

* Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame	Description
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month	1,3,6,12 month	thyroid-stimulating hormone (TSH), T4, T3

Secondary

Measure	Time frame	Description
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy	1,3,6,12 month	Hypothyroidism index

Other

Measure	Time frame	Description
Change of thyroid volume	1,3,6 and 12 months	Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography

Countries

Iran

Contacts

Primary ContactSeyed Rasoul Zakavi, MD. IBNM

Zakavir@mums.ac.ir+98-511 8012799

Backup ContactNarjess Ayati, MD. FEBNM

Ayatin@mums.ac.ir+98-511 8012782

Outcome results

None listed

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