Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/11/2009
Date assigned
20/01/2010
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dan Yun Chen

ORCID ID

Contact details

Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Zhongshan Road Ⅱ
1st
Guangzhou
510080
China
chendanyun@sohu.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

12-year prospective, randomised, open-label blinded endpoint study (PROBE) to estimate the optimum dose for radioiodine treatment of Graves' disease

Acronym

Study hypothesis

Dose optimisation in Graves' disease has been targeted such as to avoid a large number of recurrences or uncured patients. There was no particular focus on a low hypothyroidism rate. We hypothesise that there is an optimum individual dose resulting in a lowest uncured hyperthyroidism or recurrence rate and a low hypothyroidism rate at the same dose concept. An optimised dose concept would be desirable for two reasons:
1. To limit use of 131I for radiation safety issues
2. To limit hypothyroidism rate and consecutive need of replacement therapy. It seems to be an important factor in regions where patients have limited resources or, where access to medical supplies is limited.

Ethics approval

Dongshan Ethics Committee approved in April 1997

Study design

Prospective randomised open-label blinded end point study with intention-to-treat principle

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact either schneider_P@nuklearmedizin.uni-wuerzburg.de (for a translated English version) or chendanyun@sohu.com (for a Chinese version) to request a patient information sheet

Condition

Graves' disease

Intervention

Intervention group: Participants received one application of 131I (oral), followed by a second application after 3 months, if the first was unsuccessful. The dose/activity of 131I (in MBq) was determined using a clinical score system, the gland mass, and the 24 hours uptake of a test activity. Follow up was initially two-weekly, then monthly, and, after the patient became stable in 6-monthly intervals.

Intervention type

Drug

Phase

Not Applicable

Drug names

Radioiodine

Primary outcome measures

Assessed annually, that is every 12 months after first therapeutic intervention for each patient, ending year 12:
1. Euthyroidism
2. Hyperthyroidism
3. Recurrence
4. Hypothyroidism
5. Subclinical hypothyroidism

Secondary outcome measures

The sum dose of 131-radioiodine which was necessary to achieve therapeutic primary outcomes at the end of the study. It was assessed 3 months after inclusion and after a patient had administered or not a second treatment dose. The outcomes measure resulted from 5 groups of dose-ranges of radioiodine, beginning with a low dose-range and ending with a high dose-range. The individual dose to be adminstered was determined according to these 5 range groups modulated by a clinical 7 step score.

Overall trial start date

20/04/1997

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed hyperthyroid patients diagnosed Graves' disease
2. Patients with Graves' disease and anti thyroid drugs after 2 weeks withdrawal
3. Elevated levels of a recent set of general serum and thyroid function tests, confirming hyperthyroidism
4. 24-hour 131I-uptake greater than or equal to 40%
5. If 131I-uptake less than 40%, restriction of food or drug rich in iodine, retest until uptake was greater than or equal to 40%
6. Aged 8 years to no age limit, males and females

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

600 patients randomised to 5 groups of 120 each

Participant exclusion criteria

1. Severe liver or kidney damage
2. Agranulocytosis
3. Pregnancy or lactation
4. Less than 8 years of age

Recruitment start date

20/04/1997

Recruitment end date

31/12/2009

Locations

Countries of recruitment

China

Trial participating centre

Sun Yat-sen University
Guangzhou
510080
China

Sponsor information

Organisation

Sun Yat-Sen University (China)

Sponsor details

The First Affiliated Hospital
Zhongshan Road Ⅱ
1st
Guangzhou
510080
China
chendanyun@sohu.com

Sponsor type

University/education

Website

http://www.gzsums.net/yiyxx/e-yiygaik.asp

Funders

Funder type

University/education

Funder name

Sun Yat-Sen University (China)

Alternative name(s)

SYSY

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

China

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21563916

Publication citations

  1. Results

    Chen DY, Schneider PF, Zhang XS, He ZM, Jing J, Chen TH, Striving for euthyroidism in radioiodine therapy of Graves' disease: a 12-year prospective, randomized, open-label blinded end point study., Thyroid, 2011, 21, 6, 647-654, doi: 10.1089/thy.2010.0348.

Additional files

Editorial Notes