The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
NCT ID: NCT02393183
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2019-07-15
2022-12-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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)
ASTED
A tablet of ASTED will be taken twice a day
Selenium
Selenium (100mic) Twice daily
Selenium
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
Placebo
Placebo Twice daily
Placebo
A tablet of Placebo (same shape and color) will be taken twice a day
Interventions
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ASTED
A tablet of ASTED will be taken twice a day
Selenium
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
Placebo
A tablet of Placebo (same shape and color) will be taken twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No active state (Clinical activity score of less than 3).
3. No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
4. 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.
5. Age 18-70 years.
Exclusion Criteria
2. Pregnancy
3. Drug and/or alcohol abuse
4. Severe concomitant illness
5. Inability to comply with the study protocol
6. No informed consent
7. Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
8. Developing more severe TED in the course of the trial so that requires steroid treatment.
18 Years
70 Years
ALL
No
Sponsors
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Iran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Mohsen B Kashkouli, MD
Role: STUDY_DIRECTOR
Iran University of Medical Sciences
Locations
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Rassoul Akram Hospital
Tehran, , Iran
Countries
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Other Identifiers
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106955-24580-124-03-93
Identifier Type: -
Identifier Source: org_study_id
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