The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- ASTED
- Conditions
- Thyroid Eye Disease
- Sponsor
- Iran University of Medical Sciences
- Locations
- 1
- Primary Endpoint
- Change of total eye score (NOSPECS severity score)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
- •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.
Arms & Interventions
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)
Intervention: ASTED
Selenium
Selenium (100mic) Twice daily
Intervention: Selenium
Placebo
Placebo Twice daily
Intervention: Placebo
Outcomes
Primary Outcomes
Change of total eye score (NOSPECS severity score)
Time Frame: 0, 3, 6 months
Change of eye score during the study period
Secondary Outcomes
- Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)(0, 3, 6 months)