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

Thyroid Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02393183
• Other study ID #: 106955-24580-124-03-93
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 15, 2019
• Est. completion date: December 15, 2022

Study information

• Verified date: September 2023
• Source: Iran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• ASTED
A tablet of ASTED will be taken twice a day

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

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rassoul Akram Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total eye score (NOSPECS severity score)	Change of eye score during the study period	0, 3, 6 months
Secondary	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	0, 3, 6 months