The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204359
Recruitment Status : Unknown
Verified May 2015 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 17, 2010
Last Update Posted : May 25, 2015
Information provided by:
Sun Yat-sen University

September 15, 2010
September 17, 2010
May 25, 2015
July 2007
July 2016   (Final data collection date for primary outcome measure)
The rate of Hypothyroidism after Iodine 131 treatment [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01204359 on Archive Site
The side effect to Infiltrative exophthalmos after Iodine 131 treatment [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions
"5010 Clinical Research Programme"of Sun Yat-sen University
Iodine 131 (131I) treatment on Graves disease and Graves ophthalmopathy relationship has always been the focus of debate. Majority view is that the current treatment does not increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But the merger with severe proptosis in patients with Graves , especially infiltrative exophthalmos , the application of 131I treatment will induce or aggravate not yet reached consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. To further promote the standardization of 131I treatment of Graves disease on basis.
no more description
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
  • Hypothyroidism
  • Exophthalmos
Radiation: Iodine 131
iodine 131,185、370、555mBq,6 months
No Intervention: follow-up
Intervention: Radiation: Iodine 131
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed.

Exclusion Criteria:

  • 131I treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy
Sexes Eligible for Study: All
8 Years to 90 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Sun Yat-sen University
Not Provided
Principal Investigator: SUN YAT-SEN UNIVERSITY ningyi jiang, professor Sun Yat-sen University
Sun Yat-sen University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP