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

Study Overview
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Brief Summary
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This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED: β- Carotene (30 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60-200 IU Calcium phosphate dihydrate (40 mg) Zinc oxide (4 mg, elemental) Copper gluconate (3.5 mg) Sodium selenite 23 mg= Selenium 100 µg 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
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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. 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. 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. 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. To determine the rate of side effects in each arm and make a comparison.

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

Conditions
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Thyroid Eye Disease

Intervention / Treatment
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* Drug: ASTED
* Dietary Supplement: Selenium
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild TED of less than 18 months duration (as recorded by the patient). No active state (Clinical activity score of less than 3). No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet). Euthyroidism as a result of remission after a course of antithyroid drug (ATD) therapy, or euthyroidism for at least 2 months since commencing ATD or after thyroidectomy, or euthyroidism for at least 6 months after radioiodine therapy. Hypothyroid patients after thyroidectomy or radioiodine were replaced with levothyroxine. Euthyroidism was defined as normal serum free thyroxine, total or free triiodothyronine concentrations, and thyrotropin (TSH) levels below 4 mU/Liter Patients were kept euthyroid for the whole duration of the study. Age 18-70 years. Exclusion Criteria: TED severity of more than mild TED. Pregnancy Drug and/or alcohol abuse Severe concomitant illness Inability to comply with the study protocol No informed consent Use of selenium- or vitamin/minerals-containing preparations in the last 3 months. Developing more severe TED in the course of the trial so that requires steroid treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASTED<br>Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) β- Carotene (30 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60-200 IU Calcium phosphate dihydrate (40 mg) Zinc oxide (4 mg, elemental) Copper gluconate (3.5 mg) Sodium selenite 23 mg= Selenium 100 µg Nicotinamide (a form of vit.B3) (10 mg) | Drug: ASTED<br>* A tablet of ASTED will be taken twice a day<br>* Other names: Antioxidant Supplement for Thyroid Eye Disease;|
| Active Comparator: Selenium<br>Selenium (100mic) Twice daily | Dietary Supplement: Selenium<br>* A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day<br>|
| Placebo Comparator: Placebo<br>Placebo Twice daily | Other: Placebo<br>* A tablet of Placebo (same shape and color) will be taken twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total eye score (NOSPECS severity score) | Change of eye score during the study period | 0, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) | Change of score of thyroid eye disease Quality of life during study period | 0, 3, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, Graves' ophthalmopathy, Thyroid eye disease, Severity score, Activity score, Quality of life