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Effect of selenium in patients with mild to moderate graves' ophthalmopathy

Randomized clinical trial for assessment of effects of selenium supplementation on patients with mild to moderate Graves’ ophthalmopathy in selenium rich area

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0004040
Enrollment
84
Registered
2019-06-05
Start date
2019-05-14
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

Drug : Intervention group: Selenium 100microgram twice a day, vitamin complex once a day for 6 months Control group: vitamin complex once a day for 6 months

Sponsors

Chung-Ang Univerisity Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Patients with mild or moderate Graves' ophthalmopathy - Patients diagnosed with mild or moderate Graves' ophthalmopathy by an ophthalmologist - NO SPECS class 2a or 2b patients (conjunctival edema, eyelid edema) - Patients with exophthalmos = 22 mm - Patients who did not have other treatment for Graves' 2 Graves disease patient with normal thyroid function test - Patients with Graves' disease who are on antithyroid medication and whose thyroid function tests are normal for more than 2 months. - Graves' disease was treated with radioactive isotope therapy for patients who had been treated with radioisotope for more than 6 months but whose thyroid function test was normal - Patients with Graves' disease who developed hypothyroidism after treatment of antithyroid drugs, radioisotope therapy, and surgical treatment should be treated with thyroid hormone therapy for at least 6 months before the study, - Patients diagnosed with Graves' ophthalmopathy by an ophthalmologist but who were still before thyrotoxicosis and thyroid receptor antibody positive 3 Those who voluntarily signed the agreement

Exclusion criteria

Exclusion criteria: ? Those who do not voluntarily agree to clinical trials ? Severe Graves ophthalmopathy - Patients with NO SPECS class 2C (soft tissue involvement, orbital edema, etc.) - Patients with exophthalmos> 22 mm - Patients with ocular torticollis when there is diplopia or silence - Patients with visual neuropathy - A severe Graves eye disease when an ophthalmologist judges ? Patients who have received steroid or selenium treatment within the last 3 months ? Patients who fall under the contraindication of drug administration I. Patients who are hypersensitive to the drug or its components II. Selenium toxic patient III. Hereditary fructose intolerance, glucose-galactose uptake disorder or white sugar-isomaltase deficiency ? Others Patients with other serious diseases such as the following I. Patients with heart and circulatory dysfunction - those diagnosed with heart failure, coronary artery disease, arrhythmia, and currently taking medication II. Patients with renal impairment - GFR <60 ml / min III. Patients with hypoproteinemia - Albumin <3.3 g / dL IV. Pregnant or potentially pregnant women V. Maternity VI. Patient receiving medical treatment VII. Patients with gastrointestinal diseases such as peptic ulcer, chronic ulcerative colitis, localized colitis ? Other, if judged by the researcher to be inappropriate for participation in this clinical trial

Design outcomes

Primary

MeasureTime frame
Improvement of quality of life score of thyroid ophthalmopathy

Secondary

MeasureTime frame
Ophthalmological improvement

Countries

Korea, Republic of

Contacts

Public ContactHwa Young Ahn

Chung-Ang University

ahy0809@gmail.com+82-2-6299-3152

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 11, 2026