Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/12/2007
Date assigned
21/12/2007
Last edited
21/12/2007
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

Dr Dan Yun Chen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

A 9-year Prospective, Randomized, Open-label, Blinded End point (PROBE) treatment study to compare the efficacy of 131I versus anti-thyroid drugs in the treatment of hyperthyroidism

Acronym

Study hypothesis

1. 131I therapy is considered cheaper, safer, simpler to use and has less side effects compared with anti-thyroid drugs
2. Time to cure hyperthyroidism using radioiodine (131I) is shorter compared with anti-thyroid drugs
3. Rate of hypothyroidism when using 131I is low, if carefully dosed

Ethics approval

Approved by the Dongshan Ethics Committee on 22 December 1997.

Study design

Prospective, randomized, open-label, blinded end point study, with intention-to-treat principle.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hyperthyroidism

Intervention

Recruitment took place in the province of Guangdong, China. Participants were randomised to the intervention and control groups in equal numbers.

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 estimated using a standard procedure (mass of the lesion or gland, uptake of a test activity after 24 hours) to achieve a gland dose to cure hyperthyroidism.

Control group: Administration of an anti-thyroid drug, either methimazole (oral) or propylthiouracil (oral), as needed at a dose aimed at achieving euthyroidism, for at least 18 months. The treatment continued until primary outcome data were collected. If euthyroidism was not achieved, the patient was treated with anti-thyroid drug until the end of the study (98.4 +/- 5.5 months [range: 89 - 108 months]).

Intervention type

Drug

Phase

Not Specified

Drug names

131I, anti-thyroid drugs (methimazole and propylthiouracil)

Primary outcome measures

The outcomes above were assessed at monthly follow-up visits during the first year and then every 3 to 6 months thereafter. Duration of follow-up was 98.4 +/- 5.5 months (range: 89 - 108 months) for participants who were included in both primary and secondary outcomes measures.
1. Euthyroidism
2. Persistent hyperthyroidism
3. Recurrence
4. Clinical hypothyroidism
5. Sbclinical Hypothyroidism

Secondary outcome measures

The outcomes above were assessed at monthly follow-up visits during the first year and then every 3 to 6 months thereafter. Duration of follow-up was 98.4 +/- 5.5 months (range: 89 - 108 months) for participants who were included in both primary and secondary outcomes measures.
1. Changes in ophthalmopathy and complications
2. Side effects
3. Safety
4. Efficacy

Overall trial start date

01/01/1998

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed hyperthyroid patients
2. No previous thyroid treatment
3. Elevated levels of a recent set of general serum and thyroid function tests, indication of hyperthyroidism
4. 24-hour uptake of 131I >=40%

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

460

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

01/01/1998

Recruitment end date

31/01/2007

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
Guangzhou
510080
China
chendanyun@sohu.com

Sponsor type

University/education

Website

http://www.sysu.edu.cn/en/index.html

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

Publication citations

Additional files

Editorial Notes