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

Sponsor

Iran University of Medical Sciences (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02393183

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

β- Carotene (3 mg)
Vit C (100 mg)
Vit E (Alpha-Tocopherol Acetate): 60 IU
Vit D (500 IU)
Zinc (4 mg, elemental)
Copper (0.5 mg, elemental)
Selenium 100 µg (as Sodium Selenite) in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Drug: ASTED Dietary Supplement: Selenium Other: Placebo	Phase 2/Phase 3

Detailed Description

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.
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.
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.
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.
To determine the rate of side effects in each arm and make a comparison.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASTED Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) β- Carotene (3 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60 IU Vit D (500 IU) Zinc (4 mg, elemental) Copper (0.5 mg, elemental) Selenium 100 µg (as Sodium Selenite)	Drug: ASTED A tablet of ASTED will be taken twice a day Other Names: Antioxidant Supplement for Thyroid Eye Disease
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

Arm

Intervention/Treatment

Experimental: ASTED

Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) β- Carotene (3 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60 IU Vit D (500 IU) Zinc (4 mg, elemental) Copper (0.5 mg, elemental) Selenium 100 µg (as Sodium Selenite)

Drug: ASTED

A tablet of ASTED will be taken twice a day

Other Names:

Antioxidant Supplement for Thyroid Eye Disease

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

Outcome Measures

Primary Outcome Measures

Change of total eye score (NOSPECS severity score) [0, 3, 6 months]
Change of eye score during the study period

Secondary Outcome Measures

Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL) [0, 3, 6 months]
Change of score of thyroid eye disease Quality of life during study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mild TED of less than 18 months duration (as recorded by the patient).
No active state (Clinical activity score of less than 3).
No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
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.
Age 18-70 years.

Exclusion Criteria:

TED severity of more than mild TED.
Pregnancy
Drug and/or alcohol abuse
Severe concomitant illness
Inability to comply with the study protocol
No informed consent
Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
Developing more severe TED in the course of the trial so that requires steroid treatment.