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

Phase 2

Withdrawn

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Twice daily
ASTED	ASTED	Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) 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)
Selenium	Selenium	Selenium (100mic) Twice daily

Primary Outcome Measures

Name	Time	Method
Change of total eye score (NOSPECS severity score)	0, 3, 6 months	Change of eye score during the study period

Secondary Outcome Measures

Name	Time	Method
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)	0, 3, 6 months	Change of score of thyroid eye disease Quality of life during study period

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