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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement B-Carotene (6 mg) + Vit.C (200 mg) + Vit.E (200 mg) + Vit. Nicotinamide (20 mg) + Selenium (200 mic.)+ Zinc oxide (8 mg) + Copper oxide (1mg) +Mangeneschloride (1.8 mg) in patients with mild Graves' orbitopathy according to EUGOGO classification.

Detailed Summary:

  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.

Sponsor: Iran University of Medical Sciences

Current Primary Outcome: Change of total eye score (NOSPECS severity score) [ Time Frame: 0, 3, 6 months ]

Change of eye score during the study period


Original Primary Outcome: Change of total eye score (NOSPECS severity score) [ Time Frame: 0, 3, 6 months ]

Current Secondary Outcome: Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) [ Time Frame: 0, 3, 6 months ]

Change of score of thyroid eye disease Quality of life during study period


Original Secondary Outcome: Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) [ Time Frame: 0, 3, 6 months ]

Information By: Iran University of Medical Sciences

Dates:
Date Received: March 7, 2015
Date Started: September 2017
Date Completion: May 2021
Last Updated: March 11, 2017
Last Verified: March 2017