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A multicenter randomized controlled study of selenium and 99Tc-MDP vs placebo in the prevention and improvement of Graves' ophthalmopathy treated by radioactive iodine for patients with hyperthyroidism

A multicenter randomized controlled study of selenium and 99Tc-MDP vs placebo in the prevention and improvement of Graves' ophthalmopathy treated by radioactive iodine for patients with hyperthyroidism - selenium and 99Tc-MDP in the prevention and improvement of Graves' ophthalmopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066740
Enrollment
Unknown
Registered
2022-12-15
Start date
2022-12-30
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Patients with Graves' hyperthyroidism and mild to moderate thyroid-associated ophthalmopathy

Interventions

Selenium treatment group:100 microgram bid
placebo:Starch 100 micrograms bid
99Tc-MDP treatment group:99Tc-MDP 20mg qod×15, intravenous infusion, 20mg qod×15 after 2 months

Sponsors

Shanghai Tenth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for GD hyperthyroidism (GH); 2) Meet the diagnostic criteria for mild to moderate GO; 3) Over 16 years old; 4) Male and female gender is not limited; 5) 131I treatment of GH.

Exclusion criteria

Exclusion criteria: 1) Under the age of 16; 2) GO treatment such as orbital surgery and orbital irradiation; 3) Severe or severe GO or severe loss of vision; 4) Unable to agree to participate in the research; 5) The thyroid iodine uptake rate is less than or equal to 30%; 6) Selenium allergy; 7) The follow-up time is less than 6 months; 8) Treatment contraindications, such as pregnancy/pregnancy preparation, lactation, myocardial infarction, severe liver and kidney diseases, etc.

Design outcomes

Primary

MeasureTime frame
overall effective rate;overall effective rate;

Secondary

MeasureTime frame
GO-QoL;GO recurrence rate;Clinical Activity Score (CAS);

Countries

China

Contacts

Public ContactMa Chao

Shanghai Tenth People’s Hospital

ponymachao@163.com18721288964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026