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

Primary Purpose

Thyroid Eye Disease

Status
Withdrawn
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
ASTED
Selenium
Placebo
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Antioxidant, Graves' ophthalmopathy, Thyroid eye disease, Severity score, Activity score, Quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rassoul Akram Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ASTED

Selenium

Placebo

Arm Description

Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) β- Carotene (30 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60-200 IU Calcium phosphate dihydrate (40 mg) Zinc oxide (4 mg, elemental) Copper gluconate (3.5 mg) Sodium selenite 23 mg= Selenium 100 µg Nicotinamide (a form of vit.B3) (10 mg)

Selenium (100mic) Twice daily

Placebo Twice daily

Outcomes

Primary Outcome Measures

Change of total eye score (NOSPECS severity score)
Change of eye score during the study period

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2015
Last Updated
September 26, 2023
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02393183
Brief Title
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
Official Title
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Do not access to the drug
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED: β- Carotene (30 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60-200 IU Calcium phosphate dihydrate (40 mg) Zinc oxide (4 mg, elemental) Copper gluconate (3.5 mg) Sodium selenite 23 mg= Selenium 100 µg 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease
Keywords
Antioxidant, Graves' ophthalmopathy, Thyroid eye disease, Severity score, Activity score, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASTED
Arm Type
Experimental
Arm Description
Antioxidant Supplements for TED (ASTED): to evaluate the effect of selected antioxidant vitamins and minerals supplement (Twice daily) β- Carotene (30 mg) Vit C (100 mg) Vit E (Alpha-Tocopherol Acetate): 60-200 IU Calcium phosphate dihydrate (40 mg) Zinc oxide (4 mg, elemental) Copper gluconate (3.5 mg) Sodium selenite 23 mg= Selenium 100 µg Nicotinamide (a form of vit.B3) (10 mg)
Arm Title
Selenium
Arm Type
Active Comparator
Arm Description
Selenium (100mic) Twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Twice daily
Intervention Type
Drug
Intervention Name(s)
ASTED
Other Intervention Name(s)
Antioxidant Supplement for Thyroid Eye Disease
Intervention Description
A tablet of ASTED will be taken twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Intervention Description
A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A tablet of Placebo (same shape and color) will be taken twice a day
Primary Outcome Measure Information:
Title
Change of total eye score (NOSPECS severity score)
Description
Change of eye score during the study period
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
Change of score of thyroid eye disease Quality of life questionnaire (TED-QOL)
Description
Change of score of thyroid eye disease Quality of life during study period
Time Frame
0, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen B Kashkouli, MD
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Rassoul Akram Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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