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

September 26, 2023 updated by: Iran University of Medical Sciences

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

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

  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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Mild TED of less than 18 months duration (as recorded by the patient).
  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:

  1. TED severity of more than mild TED.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Selenium
Selenium (100mic) Twice daily
Dietary supplement: Selenium
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
Placebo Comparator: Placebo
Placebo Twice daily
Other: Placebo
A tablet of Placebo (same shape and color) will be taken twice a day
Experimental: 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)
Drug: ASTED
A tablet of ASTED will be taken twice a day
Other Names:
  • Antioxidant Supplement for Thyroid Eye Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of total eye score (NOSPECS severity score)
Time Frame: 0, 3, 6 months
Change of eye score during the study period
0, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Investigators

  • Study Director: Mohsen B Kashkouli, MD, Iran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Estimated)

June 15, 2022

Study Completion (Estimated)

December 15, 2022

Study Registration Dates

First Submitted

March 7, 2015

First Submitted That Met QC Criteria

March 14, 2015

First Posted (Estimated)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106955-24580-124-03-93

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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