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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Sun Yat-sen University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204359
First Posted: September 17, 2010
Last Update Posted: May 25, 2015
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.
Information provided by:
Sun Yat-sen University
  Purpose
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.

Condition Intervention Phase
Hypothyroidism Exophthalmos Radiation: Iodine 131 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: "5010 Clinical Research Programme"of Sun Yat-sen University

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The rate of Hypothyroidism after Iodine 131 treatment [ Time Frame: one year ]

Secondary Outcome Measures:
  • The side effect to Infiltrative exophthalmos after Iodine 131 treatment [ Time Frame: one year ]

Estimated Enrollment: 627
Study Start Date: July 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: follow-up Radiation: Iodine 131
iodine 131,185、370、555mBq,6 months

Detailed Description:
no more description
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204359


Contacts
Contact: ningyi jiang, bachelor +8613602753179 ningyij@163.net

Locations
China, Guangdong
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Ningyi Jiang, bachelor    +8613602753179    ningyij@163.net   
China
Ningyi Jiang Recruiting
Guangzhou, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: SUN YAT-SEN UNIVERSITY ningyi jiang, professor Sun Yat-sen University
  More Information

Responsible Party: ningyi jiang, SUN YAT-SEN UNIVERSITY
ClinicalTrials.gov Identifier: NCT01204359     History of Changes
Other Study ID Numbers: 2007022
First Submitted: September 15, 2010
First Posted: September 17, 2010
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Hypothyroidism
Exophthalmos
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs