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The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)

Thyroid Eye Disease Clinical Trial

Official title:
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial

Clinical Trial Summary

This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED: 1. β- Carotene (30 mg) 2. Vit C (100 mg) 3. Vit E (Alpha-Tocopherol Acetate): 60-200 IU 4. Calcium phosphate dihydrate (40 mg) 5. Zinc oxide (4 mg, elemental) 6. Copper gluconate (3.5 mg) 7. Sodium selenite 23 mg= Selenium 100 µg 8. Nicotinamide (a form of vit.B3) (10 mg) in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.

Clinical Trial Description

1. To determine total eye score (NOSPECS severity score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison. 2. To determine Score of thyroid eye disease Quality of life questionnaire (TED-QOL) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison. 3. To determine clinical activity score (CAS Score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison. 4. To determine Serum thyroid auto-antibodies (Anti thyroid peroxidase (TPO), Anti-thyrogluboline) and Thyroid function test (Free T4, T3, and TSH) level before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison. 5. To determine the rate of side effects in each arm and make a comparison. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02393183
Study type Interventional
Source Iran University of Medical Sciences
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date July 15, 2019
Completion date December 15, 2022
View Details
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