Study of effects of selenium supplement in thyroid eye disease patients, A double-blind, randomized controlled trial

Phase 4

• Conditions: Clinical symptoms of the patient with thyroid eye disease and selenium level; selenium, thyroid eye disease

• Registration Number: TCTR20220725003
• Lead Sponsor: Office of Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Study Completion: 2022-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patient aged 20 years or more who was diagnosed with thyroid disease and received the treatment no longer than 3 months
1.1 Thyroid diseases includes hyperthyroidism, hypothyroidism and autoimmune thyroid or
1.2 Patients who diagnosed with thyroid disease and have euthyroid status
2. Healthy participants aged 20 years or more
2.1 No history of thyroid disease
2.2 No status of malnutrition

Exclusion Criteria

1. Patients who received thyroid surgery
2. Patients who received radiotherapy
3. Patients who have lived in Thailand less than a year
4. Patients who have serious illness (e.g. cancer, acute infection)
5. Patient who have severe thyroid eye disease and the treatment by steroid, radiotherapy, or orbital surgery are needed or planned
6. Patient who have selenium level more than 400 micrograms/liter
7. Patient with chronic kidney disease
8. Pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical symptoms and signs of the eyes at 0, 3, 6 and 12 months clinical activity score,subjective quality of life at 0, 3, 6 and 12 months Graves' orbitopathy quality of life,selenium level at 0, 3, 6 and 12 months micrograms per liter

Secondary Outcome Measures

Name	Time	Method
Thyroid-Stimulating Hormone at 0, 3, 6 and 12 months milliunits per liter,Triiodothyronine free at 0, 3, 6 and 12 months pg/ml,Free thyroxine at 0, 3, 6 and 12 months pg/ml,Anti-thyroglobulin antibodies at 0, 3, 6 and 12 months IU/ml,Anti-thyroidperoxidase at 0, 3, 6 and 12 months IU/ml,Selenium-rich food consumption score at day 0 points