Clinical Trial: The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial
Brief Summary: ASTED (Antioxidant Supplements for TED) trial is an investigator-initiated, randomized, triple masked, clinical trial of a selected combination of vitamins and minerals versus placebo in patients with moderate to severe thyroid eye disease. The trial has a parallel-arm design.
Detailed Summary:
Primary aim: To investigate if ASTED or as compared with placebo could affect the course of TED either by enhancing improvement or preventing worsening in patients with Moderate to severe TED thyroid eye disease (TED) based on:
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Total eye score (NOSPECS severity score) 1 Total eye score is used to assess the severity of TED, which was calculated by multiplying each class of the NOSPECS system1 (except class 0) to its grade of severity (0-3), yielding a maximum total score of 63 and a minimum total score of 0 (the higher the number the worse the severity) The overall ophthalmic outcome is a composite score based on multiple items (Soft tissue, retraction, proptosis, diplopia, and corneal involvement); the use of a composite score circumvents the problem arising from the presence of improvement in one item and simultaneous worsening in another item.
The severity score in each of the classes 1, 2, 3, and 4 will also be separately compared to evaluate the effect of different treatments on each sign.
- Score of thyroid eye disease Quality of life questionnaire (TED-QOL) 2.
Secondary outcomes measures:
To compare possible change in:
- Clinical activity score (CAS Score) 3 (7 items are scored in the beginning and 10 items are scored at 3 and 6 months)
- Serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) at 0, 3 and 6 months. Thyroid function test (Free T4, T3, and TSH) will be measured in all 3 visits0
- Side effects
Sponsor: Iran University of Medical Sciences
Current Primary Outcome:
- Mean of total eye score changes (using NOSPECS severity score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]Total eye score change during study
- Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL) [ Time Frame: baseline, 1 month, 3 months, 6 months ]Changing quality of life during study period
Original Primary Outcome:
- Mean of total eye score changes (using NOSPECS severity score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
- Mean of "thyroid eye disease Quality of life" score changes (Using TED-QOL) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
Current Secondary Outcome:
- Mean of clinical activity score changes (CAS Score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]Change of clinical activity score during study period
- Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) [ Time Frame: baseline, 1 month, 3 months, 6 months ]Change of serum thyroid auto-antibodies during study period
- Changes of thyroid function test (Free T4, T3, and TSH) Levels [ Time Frame: baseline, 1 month, 3 months, 6 months ]Change of thyroid function test during study period
Original Secondary Outcome:
- Mean of clinical activity score changes (CAS Score) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
- Changes of serum thyroid auto-antibodies (Anti-thyroid peroxidase (TPO), Anti-thyroglobulin) [ Time Frame: baseline, 1 month, 3 months, 6 months ]
- Changes of thyroid function test (Free T4, T3, and TSH) Levels [ Time Frame: baseline, 1 month, 3 months, 6 months ]
Information By: Iran University of Medical Sciences
Dates:
Date Received: April 11, 2015
Date Started: September 2017
Date Completion: June 2021
Last Updated: March 11, 2017
Last Verified: March 2017
