NCT02393183

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Iran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	ASTED	A tablet of ASTED will be taken twice a day
DIETARY_SUPPLEMENT	Selenium	A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
OTHER	Placebo	A tablet of Placebo (same shape and color) will be taken twice a day

Timeline

• Start date: 2019-07-15
• Primary completion: 2022-06-15
• Completion: 2022-12-15
• First posted: 2015-03-19
• Last updated: 2023-09-28

Locations

1 site across 1 country: Iran