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

NCT02393183 | Withdrawn Phase 2

• 1 other identifier: 106955-24580-124-03-93
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.β- Carotene (30 mg)
2. 2.Vit C (100 mg)
3. 3.Vit E (Alpha-Tocopherol Acetate): 60-200 IU
4. 4.Calcium phosphate dihydrate (40 mg)
5. 5.Zinc oxide (4 mg, elemental)
6. 6.Copper gluconate (3.5 mg)
7. 7.Sodium selenite 23 mg= Selenium 100 µg
8. 8.Nicotinamide (a form of vit.B3) (10 mg)

Conditions

Thyroid Eye Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of total eye score (NOSPECS severity score)

  Change of eye score during the study period

  0, 3, 6 months

Secondary Outcomes (1)

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

  0, 3, 6 months

Study Arms (3)

ASTED

EXPERIMENTAL

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

Selenium

ACTIVE COMPARATOR

Selenium (100mic) Twice daily

Dietary Supplement: Selenium

Placebo

PLACEBO COMPARATOR

Placebo Twice daily

Other: Placebo

Interventions

ASTED DRUG

A tablet of ASTED will be taken twice a day

Also known as: Antioxidant Supplement for Thyroid Eye Disease

ASTED

Selenium DIETARY_SUPPLEMENT

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

Selenium

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

Rassoul Akram Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Selenium

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Mohsen B Kashkouli, MD

  Iran University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2015
• First Posted: March 19, 2015
• Study Start: July 15, 2019
• Primary Completion: June 15, 2022
• Study Completion: December 15, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

IR (1)