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WithdrawnNCT02393183Updated Sep 28, 2023

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

A Phase 2/3 interventional study of ASTED and Selenium in Thyroid Eye Disease, sponsored by Iran University of Medical Sciences. Withdrawn at 1 site in Iran. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Iran University of Medical Sciences · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
Do not access to the drug
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.
02

Conditions studied

  • Thyroid Eye Disease

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Keywords

  • Antioxidant
  • Graves' ophthalmopathy
  • Thyroid eye disease
  • Severity score
  • Activity score
  • Quality of life
03

In context

Graves Ophthalmopathy

198 studies on the registry are indexed under Graves Ophthalmopathy; 60 are open to participants now.

Browse Graves Ophthalmopathy studies →

Lead sponsor

Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Active comparator
    Selenium

    Selenium (100mic) Twice daily

    Dietary Supplement: Selenium

  • Placebo comparator
    Placebo

    Placebo Twice daily

    Other: Placebo

Interventions

  • DrugASTED

    A tablet of ASTED will be taken twice a day

    Also known as: Antioxidant Supplement for Thyroid Eye Disease

  • Dietary supplementSelenium

    A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day

  • OtherPlacebo

    A tablet of Placebo (same shape and color) will be taken twice a day

06

What researchers measure

Primary outcomes

  1. Change of total eye score (NOSPECS severity score)

    Change of eye score during the study period

    Time frame: 0, 3, 6 months

Secondary outcomes

  1. Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)

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

    Time frame: 0, 3, 6 months

07

Study locations

1 site
  • Rassoul Akram Hospital
    Tehran, Iran
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02393183
Lead sponsor
Iran University of Medical Sciences
Responsible party
Sponsor
First posted
Mar 19, 2015
Start date
Jul 15, 2019
Primary completion
Jun 15, 2022 (estimated)
Completion
Dec 15, 2022 (estimated)
Last update
Sep 28, 2023

Study contacts

Mohsen B Kashkouli, MD
study director · Iran University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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