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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    235
  • sponsor
    Iran University of Medical Sciences
Updated on 16 January 2022
thyroxine
free thyroxine
artificial tears
thyrotropin
copper
eye disease
hypothyroidism
thyroidectomy
antithyroid drugs
vit e
minerals supplement

Summary

This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement:

  1. - Carotene (3 mg)
  2. Vit C (100 mg)
  3. Vit E (Alpha-Tocopherol Acetate): 60 IU
  4. Vit D (500 IU)
  5. Zinc (4 mg, elemental)
  6. Copper (0.5 mg, elemental)
  7. Selenium 100 g (as Sodium Selenite) in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.

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.

Details
Condition Graves' ophthalmopathy
Treatment Placebo, selenium, ASTED
Clinical Study IdentifierNCT02393183
SponsorIran University of Medical Sciences
Last Modified on16 January 2022

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